#Alkaline Water Filter in Mumbai

[aquaj1-mumbai]

Aqua J1 Purifier for Home

Aqua J1 Alka Smart RO + UV + UF + Alkaline +B12+ TDS Controller |Pre Filter and New Auto Flushing System |12 L Storage |100% RO+ Alkaline Water Saving |Suitable Till 3500 TDS | Purifier for Home

The Aqua J1 Alka Smart RO + UV + UF + Alkaline water purifier boasts an advanced filtration system, ensuring that the water you consume is free from harmful impurities. Its multi-layered filtration process removes chlorine, heavy metals, sediment, and other contaminants, delivering crystal-clear and refreshing water that not only tastes better but also promotes better health. One of the key highlights of the Aqua J1Alka Smart is its ability to ionize water, raising its pH level and creating alkaline water. Alkaline water is believed to neutralize acidity in the body, promoting better digestion and helping to maintain a healthy pH balance, which is essential for overall well-being.

best alkaline water ionizer in Mumbai

Water Ionization Technology: Look for ionizers that use advanced electrolysis technology to produce alkaline water with a pH level between 8 and 10. Additionally, consider models that offer customizable pH levels to suit your preferences.

Brand Generic

Colour           White

Special Feature       UV, UF, RO

Package Information         Dispenser

Model Name            J1

About this item

RO

UV

UF

The Aqua J1 Alka Smart Product Machine is a revolutionary device that redefines how we interact with water. From its advanced filtration system to the generation of alkaline ionized and hydrogen-rich water, this smart product machine delivers an array of health benefits. Embrace the future of water with the Aqua J1 Alka Smart and transform your life for the better.

[akarpools]

Swimming Pool Maintenance: Tips for Crystal Clear Waters All Summer Long

Having a swimming pool in your backyard is a dream come true for many homeowners. It provides a refreshing escape from the scorching summer heat and offers a perfect setting for relaxation and fun with family and friends. However, to enjoy your pool to the fullest, proper maintenance is essential. In this blog, we will provide you with expert tips to keep your swimming pool waters crystal clear all summer long. Whether you got your pool built by a swimming pool contractor in Pune, Mumbai, Delhi, Bangalore, Ghaziabad, Faridabad, or any other city, these maintenance guidelines are universally applicable.

Regular Skimming and Cleaning

One of the fundamental tasks in swimming pool maintenance is regular skimming and cleaning. Leaves, debris, insects, and other foreign materials tend to accumulate on the water surface. Use a skimmer net to remove these impurities daily. Also, invest in a pool vacuum to clean the pool floor and walls at least once a week. By doing so, you prevent these particles from sinking and clogging the pool's filters, ultimately leading to cleaner water.

Monitor Water Chemistry

Maintaining the proper chemical balance in your pool water is crucial for hygiene and swimmer comfort. Test the water regularly using a pool water testing kit. The key parameters to monitor are pH levels, chlorine/bromine levels, alkalinity, and calcium hardness. Adjust these levels as needed to prevent issues like algae growth, cloudy water, and skin/eye irritation. Consult with a Swimming Pool Contractor or professional for guidance on balancing the water chemistry effectively.

Shock the Pool Regularly

Shocking the pool involves adding a large dose of chlorine to the water to eliminate bacteria, algae, and other contaminants that regular sanitization might miss. It's essential to shock your pool on a regular basis, especially after heavy use, rainstorms, or extremely hot weather. Follow the manufacturer's instructions and safety guidelines while handling pool chemicals, and remember to keep the pool closed for swimming until chlorine levels return to the recommended range.

Maintain Proper Filtration

The pool's filtration system plays a crucial role in keeping the water clean and clear. Make sure the pool pump and filter are in good working condition. Clean the filter regularly as per the manufacturer's guidelines to prevent debris buildup. Additionally, consider running the pool pump and filter for 6 to 8 hours daily during peak swimming season to ensure effective water circulation and filtration.

Regular Inspection and Maintenance

Regularly inspect your swimming pool for any signs of leaks, cracks, or equipment malfunctions. Promptly address any issues by contacting a swimming pool contractor in your area. Proactive maintenance can prevent minor problems from escalating into costly repairs. Whether you're in Delhi, Mumbai, Pune, Bangalore, Ghaziabad, or Faridabad, having a reliable swimming pool contractor to assist with maintenance and repairs is essential for the long-term health of your pool.

Cover Your Pool When Not in Use

Using a pool cover when the pool is not in use can significantly reduce debris accumulation and water evaporation. This simple practice not only keeps your pool cleaner but also saves water and reduces chemical consumption. Invest in a high-quality pool cover that fits your pool properly and is easy to use.

Encourage Proper Pool Hygiene

Educate swimmers, especially children, about the importance of proper pool hygiene. Encourage them to shower before entering the pool to wash away any dirt, oils, or lotions on their bodies. Implement rules against urinating or spitting in the pool, as these can introduce harmful bacteria and contaminants.

By following these expert tips for swimming pool maintenance, you can ensure that your pool remains a safe and enjoyable haven throughout the summer season. 

Conclusion

At Aakar Pools, we take pride in being a leading Swimming Pool Contractor and manufacturer, catering to pool enthusiasts across Pune, Delhi, Mumbai, Bangalore, Faridabad, and Ghaziabad. With years of experience in the industry, we are committed to delivering top-notch services and products that meet the highest standards of quality and craftsmanship. As a trusted name in the swimming pool industry, we specialize in building custom-designed pools, providing efficient maintenance solutions, and offering a wide range of pool-related products. Experience excellence in swimming pool construction and management with Aakar Pools.

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What are Properties of 303 Stainless Steels/Plates?

PROPERTIES OF 303 SS steel SHEET/PLATE

Heat Treatment

Annealing - Heat to a minimum temperature of 1900ºF (1038ºC) and water quench or rapid cool by other means.

Hardening - Alloy 303 can't be hardened by thermal treatment, it can only be hardened by cold working.

Cold Forming

The cold formability of alloy 303 is adversely impacted by the high sulfur content. SS steel 303 Plates Stickiest the alloy could also be bent with a generous bend radius; however, when cold forming is required, 304 should be utilized.

Hot Forming

The high sulfur content of alloy 303 also features a detrimental impact on hot workability. SS steel 303 Plates Stickiest if hot forming is required, once more, 304 should be considered as an alternate selection.

Machining

Alloy 303 was developed specifically for simple machining. SS steel 303 Plates Stickiest the sulfur addition assists in ending turnings which reduces drag on the cutter. It produces small brittle chips and should be machined at high speeds with deep cuts and heavy feed.

Welding

Alloy 303 isn't recommended for applications requiring welding. SS steel 303 Plates Traders If it's necessary to weld the alloy, AWS E312 filter metal could also be considered.

 INNOVATIVE TECHNOLOGY of 303 SS steel SHEET/PLATE

 At Chhajed steel plates we never stop improving and developing our technologies to travel beyond our customer’s expectations. SS steel 303 Plates Traders in India, we attempt towards these goals to supply reliable products and ensure they will be fully utilized throughout their lifetime.

Stainless Steel 303 Plates may be a free machining of austenitic SS steel. The superb machinability is thanks to its sulfur content within the range of 0.15 - 0.30%. It’s good resistance to atmospheric corrosion and to several organic and inorganic chemicals. SS steel 303 Plates Distributors in Mumbai they're non-magnetic during a shielded state, but they will become slightly magnetic thanks to the introduction of or ferrite beads during cold-work or welding.

Corrosion resistance

Stainless Steel 303 Plates has relatively good resistance to atmospheric corrosion with some restrictions for marine and coastal environments. SS steel 303 Plates Suppliers in India Also, the category has good resistance to several (to put it mildly corrosion) organic and inorganic chemicals. Slightly less corrosion resistance compared to EN 1.4307 thanks to the addition of sulfur. SS  steel 303 Plates Stickiest in Mumbai Residual cutting fluid must be removed employing a degreasing process and therefore the surface must be passivized after processing to realize better corrosion resistance.

Stainless Steel 303 Plates is vulnerable to corrosion from abroad for grain from precipitation and chromium carbides, which may occur within the temperature range 550 - 850ºC. Corrosion resistance and crevice corrosion isn't low to moderate. These sorts of corrosion usually occur in acidic, neutral or slightly alkaline solutions and in media with a coffee salt content. SS steel 303 Plates Dealers in Mumbai Class SS steel 303 Plates is vulnerable to crack corrosion stress. Critical service conditions like applications during a combination of breaking load at temperatures above about 50ºC and solutions containing chlorides should be avoided.

304 SS steel hot plate the dimensions of 1000 * 2000mm thickness 45mm

Product details

303 SS steel sour free cutting austenite SS steel, to enhance performance

Steel, SS steel 303 Plates Dealers in Mumbai can add no quite 0.60% molybdenum, ablative.

Mechanical properties of SS steel 303 after stress relief annealing, tensile 515MPa, output 205MPa,

elongation hardness 40% .Standard of SS  steel 303 HRB 90-100, HRK 20-25, note: HRB100 = HRK22.9.

303 free cutting SS steel containing sulfur and selenium, respectively, for the most

Requirements of free cutting and high surface SS steel finish. 303 improve cutting performance

And resistance to heat bonding. SS steel 303 Plates Exporters in Mumbai Best for automatic lathes, bolts and nuts.

 Application

Stainless Steel 303 Plates Exporters in Mumbai Oil, electronics, industry , medicine, fabric, food, machinery, construction, atomic energy ,space, military and other industries.

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Water Filter India Trending Videos-ALKEN India's 1st RO-UV-UF purifier with alkaline miniralizer technology & stainless steel storage.

Featured Post in Water Filter India dot com - Water Filter India

Water Filter India Trending Videos-ALKEN India's 1st RO-UV-UF purifier with alkaline miniralizer technology & stainless steel storage.

Source-YouTubeLink About Company: We are one of many main water purifier producer primarily based out of Mumbai. We are into this trade since 1989. Our workplace is positioned in …

Click Here to View or Learn More - Water Filter India Trending Videos-ALKEN India's 1st RO-UV-UF purifier with alkaline miniralizer technology & stainless steel storage. .........................For more Details,Please Visit our Water Filter India dot com - Home Page Link - Water Filter India

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[kangenshopmumbai]

click here >>>CONTACT KANGEN SHOP MUMBAI

INNOVATIVE WATER TECHNOLOGY

Since 1974, Enagic has been a pioneer and innovator in alkaline water ionization technologies. By integrating scientific research with superior Japanese craftsmanship Enagic's Kangen Water® systems enhance nature's most vital life source, water, around the world.

What is Kangen Water?

The human body is comprised of 70% water, so it's not much of a stretch to say that "the basis of vitality and long life is water." If you want to feel good and be at your optimal health level, you should drink water on a daily basis. But not just any type of water.

Maintain your health with Kangen Water®

Return to the origin with drinking water that is clean, free of pollutants, containing healthy minerals and has a positive pH level.

Kangen Water® is a delicious water created from Enagic's innovative water technology. Not only do these devices filter your tap water, but they also produce ionized alkaline and acidic waters through electrolysis. These waters can be used for various purposes, including drinking, cooking, beauty, and cleaning.

click here >>>CONTACT KANGEN SHOP MUMBAI

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Alkaline Purifier Kangen Water Machine h

Alkaline Purifier Kangen Water Machine h

Alkaline Purifier Kangen Water Machine https://alkaline-purifier-kangen-water-machine.business.site/ Alkaline Water Filter Supplier in Mumbai

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Analytical Method Development and Validation for Sultamicillin Tosylate Dihydrate in Bulk and Pharmaceutical Dosage Forms by RP-HPLC

INTRODUCTION Sultamicillin Tosylate Dihydrate, chemically known as (2S,5R)-(3,3-Dimethyl-4,4,7-trioxo-4-thia-1-azobicyclohept-2-ylcarbonyl)methyl(2S,5R,6R)-6--3,3dimethyl-7-ox0-4-thia-1-azabicycloheptanes-2-carboxylatemono-4-tolunesulfonate dihydrate. This is a mutual (joint) prodrug of Ampicillin and Sulbactam compounds attached together with ester connection.

Fig.1: Chemical structure of Sultamicillin Tosylate Dihydrate This mutual prodrug is one of the antibiotics with plenty antimicrobial spectrum for the treatment of childhood pneumonia. The irretrievable β-lactamase inhibitor sulbactam has been combined chemically via ester linkages with ampicillin to form sultamicillin. It was composed of double esters of formaldehyde hydrate in which one of the hydroxyl groups is esterified with ampicillin and sulbactam. It is hydrolyzed quickly in neutral or faintly alkaline conditions, while hydrolyzed; it forms ampicillin and hydroxylmethyl sulbactam or sulbactam and hydroxylmethyl ampicillin by different routes.It is available obtainable in both oral and parenteral preparations for child (pediatric) use. Sultamicillin is also a valuable treatment option for a multiplicity of paediatric infections, bacterial infections in children including those due to β-lactamase-producing organisms. The use of β-lactam and β-lactamase inhibitor mixtures, particularly ampicillin and sulbactam, as empiric treatment or prophylaxis for number of pediatric infections are healthy established, and have been extensively reviewed over number of years. The antimicrobial action of Sultamicillin had been established in vitro against extensive range of gram-positive and negative organisms and as well as anaerobes .   Sultamicillin Tosylate Dihydrate is a white crystalline powder which is freely soluble in methanol, acetonitrile, acetone and insoluble in water, benzene, chloroform, diethyl ether. The present work is to develop and validate RP-HPLC method for the determination of Sultamicillin Tosylate Dihydrate in API and its Pharmaceutical Dosage Form. MATERIAL & METHODS A calibrated weighing balance (Shimadzu) of 1 mg sensitivity was used. A HPLC Younglin Acme 9000 series quaternary gradient pump SP 930D. HPLC system accomplished with UV 370D UV Visible detector with 20µl Rheodyne injector. Data was processed on Autochrome-3000 software. Column C18 (150 x 4.6 mm, 5µm) phenomenex with UV method analysis was performed on UV visible double beam spectrophotometer Shimadzu 1800. Mobile phase filtered through a Nylon 6,6 membrane 0.45 µm, 47mm filters (pall India Pvt.Ltd. Mumbai) using vacuum pump. Ultra sonicator (Microlean-103) was used for degassing the mobile phase. The solutions were filtered through 0.45 µ syringe filter (Phenomenex). Chemicals Sultamicillin Tosylate Dihydrate drug powder was gifted by Associated Biotech, Vill.  Kishanpura, Gurumajra Road, Baddi, India. Sultamicillin Tosylate Dihydrate tablets of 375 mg strength were purchased from the local pharmacy in Solapur under commercially available brand name Marzon (Eris Lifesciences Limited). Acetonitrile LiChrosolv®, water LiChrosolv® was purchased from Merck Specialities Pvt. Ltd, Mumbai. Method Chromatographic Conditions The chromatographic separation was performed by analytical column: phenomenex C18 column (150 x 4.6 mm, 5µm) using mobile phase acetonitrile:water(45:55) at flow rate 1.0 ml/min. with isocratic elution. The injection volume was 20 µl and the run time was 10 minute. Detection was carried out at 225 nm. Preparation of standard stock solution:  The standard stock solution of Sultamicillin Tosylate Dihydrate was prepared by transferring, accurately weighed 10 mg of Sultamicillin Tosylate Dihydrate to 10 ml of volumetric flask containing 5ml methanol and dissolved. Then volume was made up to the mark by using methanol to gives concentration 1000 µg/ml. From this 1ml of the solution was transferred to a 10 ml volumetric flask and make up the volume with mobile phase (ACN:Water) to get a concentration of 100 µg/ml of sultamicillin Tosylate Dihydrate and labelled as “Standard stock solution”. Tablet solution of Sultamicillin Tosylate Dihydrate Tablet powder weight containing equivalent 10 mg of sultamicillin Tosylate was weighed and transferred to a 10 ml volumetric flask then dissolved in the methanol LR. The volume was made up to the mark with same solvent to obtain conc. of 1000µg/ml of Sultamicillin Tosylate Dihydrate. From the resulting solution 1 ml was diluted to 10 ml with the ACN:Water (4.5:5.5) solvent to obtain conc. of 100µg/ml of Sultamicillin Tosylate Dihydrate , and labeled as ‘Std Stock Tablet Sultamicillin Tosylate Dihydrate’. Assay of sultamicillin Tosylate Dihydrate Tablet 20 tablets weighed and powdered. The powder equivalent to 10 mg of sultamicillin Tosylate dihydrate was weighed transferred into100 ml volumetric flask and dissolved in methanol LR. Solution was sonicated for 15 minutes and final volume was made up to the mark with methanol LR. 1ml of solution was transferred into 10 ml of volumetric flask and diluted up to 10ml with mobile phase and sample was analysed. Selection of wavelength The standard solution of 100µg/ml was scanned in the UV range 200-400nm. The solution showed maximum absorption at 225nm. Validation of RP-HPLC Method Specificity The chromatogram of standard solution of Sultamicillin Tosylate Dihydrate was compared with chromatogram of its degradants. Linearity From the ‘Std Stock Sultamicillin Tosylate Dihydrate’ (100µg/ml) solution, the volume quantity of  1, 2, 4, 5 and 6 ml were transferred in a series of 10ml volumetric flasks. The volume was made up to the mark with mobile phase to obtain the concentration of 10, 20, 40, 50 and 60µg/ml of Sultamicillin Tosylate  Dihydrate . The solutions were filtered through syringe filter and 20µl injected into the HPLC system and their chromatogram were recorded for 10mins. Under the chromatographic conditions as described above after getting a stable baseline. Peak areas were recorded for all the peaks. Calibration curve of Sultamicillin Tosylate Dihydrate was constructed by plotting the peak area of Sultamicillin Tosylate Dihydrate v/s conc. of Sultamicillin Tosylate Dihydrate. The correlation coefficient (r2) of least square linear regression for Sultamicillin Tosylate Dihydrate was calculated. III. Range The range of analytical method was decided from the interval between upper and lower level of calibration curves by plotting the curve. The correlation coefficient (r2) of least square linear regression for Sultamicillin Tosylate Dihydrate was calculated. Precision The precision of an analytical method was studied by performing Repeatability and intermediate precision. a) Repeatability: From the ‘Std Stock Sultamicillin Tosylate Dihydrate’ (100µg/ml) solution, 2ml was transferred in 10ml volumetric flasks. The volume was made up to the mark with mobile phase to obtain the conc. of 20µg/ml of Sultamicillin Tosylate Dihydrate. The solution was filtered through syringe filter and 20µl injected into the HPLC system and its chromatogram was recorded under the same chromatographic conditions after getting a stable baseline. Peak area was recorded. The procedure was repeated for thrice. Limit of Detection Detection limit was determined based on the standard deviation of peak areas of same concentrations i.e. Standard solution of Sultamicillin Tosylate Dihydrate (20µglml) prepared six times and LOD calculated by the following formulae. LOD = 3.3(SD/S) Where, SD- Standard deviation; S- Slope of Curve Limit of Quantitation Quantitation limit was determined based on the standard deviation of peak areas of same concentrations i.e. Standard solution of Sultamicillin Tosylate Dihydrate (20µglml) prepared six times and LOQ calculated by the following formulae. LOQ calculated by the following formulae. LOQ = 10(SD/S) Where, SD- Standard deviation; S- Slope of Curve VII. Robustness         The standard solution of (20µg/ml) was prepared and analyzed at different flow rates (0.9, 1.0, 1.1 ml/min) and at different wavelengths (224, 225, and 226). VIII. System Suitability Sample solutions of Sultamicillin Tosylate Dihydrate (50µg/ml) were prepared and analyzed six times. Chromatograms were studied for different parameters such as tailing factor, resolution and theoretical plates to see that whether they comply with the recommended limit or not. Accuracy Recovery study was carried out by standard addition method by adding the known amount of sultamicillin Tosylate dehydrate to preanalysed sample at three different conc. level i.e. 80%, 100%, 120% of assay conc. and percent recovery were calculated. 0.5 ml tablet solution was transferred to 4 different 10ml volumetric flasks (Labelled as blank, 80%, 100%, 120%) separately and 0, 1.6, 2, 2.4ml of 100µg/ml ‘standard solution’ was added respectively and the volume was made up to the mark with mobile phase. and these samples were analysed. RESULTS AND DISCUSSION Determination of wavelength of maximum absorption The wavelength of maximum absorption was found to be 225 nm. Hence HPLC analysis was carried out at 225nm.

Fig 2: Wavelength of maximum absorption of Sultamiciilin Tosylate Specificity

Fig 3: Chromatogram of Sultamicillin Tosylate Dihydrate with degradants               Linearity The linearity of this method was determined at the range from 10-60µg/ml for Sultamicillin Tosylate Dihydrate. The regression equation was found to be Y=8.7304x+5.5409 be, r2=0.9991. Table No-1: Linearity table Sr. No Concentration (µg/ml) Peak Area(mV) 1 10 98.48 2 20 176.48 4 40 349.73 4 50 438.66 5 60 535.84

Fig. 3: Linearity graph of Sultamicillin Tosylate Dihydrate

Fig.4: 0verlain chromatograms of serial dilutions of Sultamicillin Tosylate Dihydrate in optimized chromatographic conditions             The linearity for Sultamicillin Tosylate Dihydrate was found to be linear in the range of 10-60µg/ml with r2= 0.9991 and the straight line equation as Y= 8.7304x+5.5409. 4.4 Range: The range for RP-HPLC method for Sultamicillin Tosylate Dihydrate was found to be 10-60 µg/ml. 4.5 Precision The precision was evaluated as the repeatability of the method and calculated as %RSD values    for six determinations of peak area ratio performed on the same day and under the same experimental condition. 4.5.1 Repeatability Table No-2: Repeatability study for Sultamicillin Tosylate Dihydrate Injection Peak Area of sultamicllin Tosylate Dihydrate (mV) 1 176.47 2 172.61 3 178.99 4 176.28 5 173.81 6 174.41 SD 2.284508 %RSD 1.30 The percentage RSD (˂2) Values obtained shows that the method developed in précised at repeatability. 4.6 Limit of Detection Detection limit is calculated based on standard deviation of response and slope Table No-3: Limit of Detection Data of Sultamicillin Tosylate Dihydrate Sultamicillin Tosylate Dihydrate LOD(µg/ml) 0.02754 4.7 Limit of Quantification Quantification limit is calculated based on standard deviation of response and slope Table No-4: Limit of Quantification data of Sultamicillin Tosylate Dihydrate Sultamicillin Tosylate Dihydrate LOD(µg/ml) 0.08345 4.8 Robustness The robustness was investigated by achieving deliberate changes in flow rate by ±1 units from 1.1 to 0.9ml/min and change in wavelength by ±1nm that flow is at 225nm Robustness of the method was carried out at concentration of 20µg/ml and then T, Rs and N were evaluated. The system suitability parameters remained unaffected over deliberate small change in the chromatoghraphic conditions, illustrating that the method was robust over an acceptable working range of its HPLC operational parameters. Table No-5: Result of Robustness Study: Variation in flow rate and wavelength   Sr no.   Conditions   Range Investigated Retention Time (min) Theorotical Plates(N)   Resolution Tailing Factor(T) 1 Flow Rate (ml/min) 1.1 6.15 7129.9 3.56 1.22 0.9 7.58 8195.1 8.36 1.26 2 Wavelength (nm) 226 6.88 9493.3 7.91 1.25 224 6.85 5013.8 2.138 1.08 System Suitability Testing Study of resolution, tailing factor and capacity factor shows system is suitable for this method Table No-5: Results of System Suitability Parameters Analyte Retention Time (min) Tailing Factor (T) Theoretical Plates (N) Resolution (R) Sultamicillin Tosylate Dihydrate 6.9 1.34 7349.6 7.64 Required limits -- T N > 2000 R >2 Assay of Sultamicillin Tosylate Dihydrate Table No-6: Results of Assay Tablet Formulation Lable claim Amount taken µg Amount found µg Assay% Marzon 375 mg 37 38 102% Accuracy The accuracy study of method was determined through the recovery test of the samples, using known amounts of sultamicillin Tosylate dehydrate reference standard. Table No-7: Results of accuracy of Sultamicillin Tosylate Dihydrate Sr.no Level of % Recovery Amount of Tablet sample solution (ml) Amount of standard drug added (µg/ml) Amount Added µg Amount Found (µg/ml) % Recovery 1 0 0.5 0 0 0 - 2 80 0.5 1.6 16 16.28 101 3 100 0.5 2 20 20.74 103 4 120 0.5 2.4 24 24.75 103     SUMMARY AND CONCLUSION Summary Analytical method development was started with preliminary studies of the Sultamicillin Tosylate Dihydrate according to BP. The drug is freely soluble in methanol. The stock solutions of the drug were prepared in methanol. The RP-HPLC method for estimation of Sultamicillin Tosylate Dihydrate dosage form was developed. The quantification was carried out by using Phenomenex C18 column (150 mm × 4.6 mm, 5 mm) as stationary phase and acetonitrile: water (45:55) as mobile phase. Mobile phase was maintained at a flow rate of 1.0ml/min. The UV detector was operated at 225 nm and  Sultamicillin Tosylate Dihydrate eluted at 6.90 min. The developed RP-HPLC method can be successfully applied for the routine analysis of Sultamicillin Tosylate Dihydrate. Table No-8: Summary of RP-HPLC Method of Sultamicillin Tosylate Dihydrate Sr. No. Parameters Sultamicillin Tosylate Dihydrate 1. Linearity Range (μg/ml) 10-60 2. Regression Equation (y = mx+c) 8.730x+5.540 3. Correlation Coefficient (r2) 0.999 4. LOD (μg/ml) 0.02754 5. LOQ (μg/ml) 0.08345 6. Repeatability (%RSD) 1.06 7. Robustness(%RSD) Flow Rate Wavelength 11.10% 23.94%   Conclusion In conclusion, the proposed HPLC method is simple, accurate, reproducible method for estimation of Sultamicillin Tosylate Dihydrate in bulk and pharmaceutical formulation.  This method shows Assay of Sultamicillin Tosylate Dihydrate within the specified limit. The method shows no interference by the excipients. The statistical parameters and recovery data reveals the good accuracy and precision of the proposed method.  Finally, since no pharmacopoeial method for determination of Sultamicillin Tosylate Dihydrate in bulk and pharmaceutical formulations have been reported yet, the proposed method could be useful and suitable for the estimation of the Sultamicillin Tosylate Dihydrate in bulk and pharmaceutical dosage forms. ACKNOWLEDGEMENT: The authors are grateful to Principal of D.S.T.S. Mandal’s College of pharmacy, Solapur, Maharashtra, India for providing us the research facility. Drug powder was gifted by Associated Biotech and grateful to Mr. Vichitra (Medicef Pharma) REFERENCES Nahler, G. (2009). International Conference on Harmonisation (ICH). In Dictionary of Pharmaceutical Medicine(pp. 96-96). Springer, Vienna. https://doi.org/10.1007/978-3-211-89836-9_719 Sadhana, k., Vasanth, P. M, Ramesh, T, Ramesh Malothu. (2013). Development of New Validated Method for the Determination OF Sultamicillin Tosylate Dihydrate in Tablet Dosage Forms By RP-HPLC. IJPSR, 3(1), 14-16. Kumar, V. J., Gupta, P. B., Kumar, K. P., Ray, U. K., Sreenivasulu, B., Kumar, G. S., & Mukkanti, K. (2011). Identification, isolation and characterization of a new degradation product in sultamicillin drug substance. Journal of pharmaceutical and biomedical analysis, 54(3), 582-587. https://doi.org/10.1016/j.jpba.2010.09.016, PMid:20934824 Japanese Pharmacoepoeia 15 Edition. 1- 1654. https;//en.wikipedia.org/sultamicillin. S. Muvvala, V.N. Rantakaram and R.R. Nadendla. (2012) A Validated RP-HPLC Method for the Estimation of Febuxostat in Bulk Drugs. Int. J. Pharm tech. Res., 4(4), 1352-1366. Lasan V. M, Patel S. A. (2015). Analytical Method Development And Validation for Escitalopran oxalate in pharmaceutical Dosage forms by HPLC Methods. International Journal for Pharmaceutical Research Scholars, 4(1), 19-24. Dinesh Reddy Salla, Vindhyakini dhanthala. (2017). A Validated RP-HPLC Method for Estimation of Rifaximin in its Bulk and Pharmaceutical Dosage forms. International Journal for Pharmaceutical Research Scholars, 6(1), 12-20. S. Potdar, M. S. Kalshetti, R.Y. Patil. (2017). Development and Validation of Novel RP-HPLC for Simultaneous Estimation of Alogliptin Benzoate and Pioglitazone Hcl in Pharmaceutical dosage form. International Journal of Chemical and Pharmaceutical Analysis, 4(3), 1-9. Read the full article

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Analytical Method Development and Validation for Sultamicillin Tosylate Dihydrate in Bulk and Pharmaceutical Dosage Forms by RP-HPLC

INTRODUCTION Sultamicillin Tosylate Dihydrate, chemically known as (2S,5R)-(3,3-Dimethyl-4,4,7-trioxo-4-thia-1-azobicyclohept-2-ylcarbonyl)methyl(2S,5R,6R)-6--3,3dimethyl-7-ox0-4-thia-1-azabicycloheptanes-2-carboxylatemono-4-tolunesulfonate dihydrate. This is a mutual (joint) prodrug of Ampicillin and Sulbactam compounds attached together with ester connection.

Fig.1: Chemical structure of Sultamicillin Tosylate Dihydrate This mutual prodrug is one of the antibiotics with plenty antimicrobial spectrum for the treatment of childhood pneumonia. The irretrievable β-lactamase inhibitor sulbactam has been combined chemically via ester linkages with ampicillin to form sultamicillin. It was composed of double esters of formaldehyde hydrate in which one of the hydroxyl groups is esterified with ampicillin and sulbactam. It is hydrolyzed quickly in neutral or faintly alkaline conditions, while hydrolyzed; it forms ampicillin and hydroxylmethyl sulbactam or sulbactam and hydroxylmethyl ampicillin by different routes.It is available obtainable in both oral and parenteral preparations for child (pediatric) use. Sultamicillin is also a valuable treatment option for a multiplicity of paediatric infections, bacterial infections in children including those due to β-lactamase-producing organisms. The use of β-lactam and β-lactamase inhibitor mixtures, particularly ampicillin and sulbactam, as empiric treatment or prophylaxis for number of pediatric infections are healthy established, and have been extensively reviewed over number of years. The antimicrobial action of Sultamicillin had been established in vitro against extensive range of gram-positive and negative organisms and as well as anaerobes .   Sultamicillin Tosylate Dihydrate is a white crystalline powder which is freely soluble in methanol, acetonitrile, acetone and insoluble in water, benzene, chloroform, diethyl ether. The present work is to develop and validate RP-HPLC method for the determination of Sultamicillin Tosylate Dihydrate in API and its Pharmaceutical Dosage Form. MATERIAL & METHODS A calibrated weighing balance (Shimadzu) of 1 mg sensitivity was used. A HPLC Younglin Acme 9000 series quaternary gradient pump SP 930D. HPLC system accomplished with UV 370D UV Visible detector with 20µl Rheodyne injector. Data was processed on Autochrome-3000 software. Column C18 (150 x 4.6 mm, 5µm) phenomenex with UV method analysis was performed on UV visible double beam spectrophotometer Shimadzu 1800. Mobile phase filtered through a Nylon 6,6 membrane 0.45 µm, 47mm filters (pall India Pvt.Ltd. Mumbai) using vacuum pump. Ultra sonicator (Microlean-103) was used for degassing the mobile phase. The solutions were filtered through 0.45 µ syringe filter (Phenomenex). Chemicals Sultamicillin Tosylate Dihydrate drug powder was gifted by Associated Biotech, Vill.  Kishanpura, Gurumajra Road, Baddi, India. Sultamicillin Tosylate Dihydrate tablets of 375 mg strength were purchased from the local pharmacy in Solapur under commercially available brand name Marzon (Eris Lifesciences Limited). Acetonitrile LiChrosolv®, water LiChrosolv® was purchased from Merck Specialities Pvt. Ltd, Mumbai. Method Chromatographic Conditions The chromatographic separation was performed by analytical column: phenomenex C18 column (150 x 4.6 mm, 5µm) using mobile phase acetonitrile:water(45:55) at flow rate 1.0 ml/min. with isocratic elution. The injection volume was 20 µl and the run time was 10 minute. Detection was carried out at 225 nm. Preparation of standard stock solution:  The standard stock solution of Sultamicillin Tosylate Dihydrate was prepared by transferring, accurately weighed 10 mg of Sultamicillin Tosylate Dihydrate to 10 ml of volumetric flask containing 5ml methanol and dissolved. Then volume was made up to the mark by using methanol to gives concentration 1000 µg/ml. From this 1ml of the solution was transferred to a 10 ml volumetric flask and make up the volume with mobile phase (ACN:Water) to get a concentration of 100 µg/ml of sultamicillin Tosylate Dihydrate and labelled as “Standard stock solution”. Tablet solution of Sultamicillin Tosylate Dihydrate Tablet powder weight containing equivalent 10 mg of sultamicillin Tosylate was weighed and transferred to a 10 ml volumetric flask then dissolved in the methanol LR. The volume was made up to the mark with same solvent to obtain conc. of 1000µg/ml of Sultamicillin Tosylate Dihydrate. From the resulting solution 1 ml was diluted to 10 ml with the ACN:Water (4.5:5.5) solvent to obtain conc. of 100µg/ml of Sultamicillin Tosylate Dihydrate , and labeled as ‘Std Stock Tablet Sultamicillin Tosylate Dihydrate’. Assay of sultamicillin Tosylate Dihydrate Tablet 20 tablets weighed and powdered. The powder equivalent to 10 mg of sultamicillin Tosylate dihydrate was weighed transferred into100 ml volumetric flask and dissolved in methanol LR. Solution was sonicated for 15 minutes and final volume was made up to the mark with methanol LR. 1ml of solution was transferred into 10 ml of volumetric flask and diluted up to 10ml with mobile phase and sample was analysed. Selection of wavelength The standard solution of 100µg/ml was scanned in the UV range 200-400nm. The solution showed maximum absorption at 225nm. Validation of RP-HPLC Method Specificity The chromatogram of standard solution of Sultamicillin Tosylate Dihydrate was compared with chromatogram of its degradants. Linearity From the ‘Std Stock Sultamicillin Tosylate Dihydrate’ (100µg/ml) solution, the volume quantity of  1, 2, 4, 5 and 6 ml were transferred in a series of 10ml volumetric flasks. The volume was made up to the mark with mobile phase to obtain the concentration of 10, 20, 40, 50 and 60µg/ml of Sultamicillin Tosylate  Dihydrate . The solutions were filtered through syringe filter and 20µl injected into the HPLC system and their chromatogram were recorded for 10mins. Under the chromatographic conditions as described above after getting a stable baseline. Peak areas were recorded for all the peaks. Calibration curve of Sultamicillin Tosylate Dihydrate was constructed by plotting the peak area of Sultamicillin Tosylate Dihydrate v/s conc. of Sultamicillin Tosylate Dihydrate. The correlation coefficient (r2) of least square linear regression for Sultamicillin Tosylate Dihydrate was calculated. III. Range The range of analytical method was decided from the interval between upper and lower level of calibration curves by plotting the curve. The correlation coefficient (r2) of least square linear regression for Sultamicillin Tosylate Dihydrate was calculated. Precision The precision of an analytical method was studied by performing Repeatability and intermediate precision. a) Repeatability: From the ‘Std Stock Sultamicillin Tosylate Dihydrate’ (100µg/ml) solution, 2ml was transferred in 10ml volumetric flasks. The volume was made up to the mark with mobile phase to obtain the conc. of 20µg/ml of Sultamicillin Tosylate Dihydrate. The solution was filtered through syringe filter and 20µl injected into the HPLC system and its chromatogram was recorded under the same chromatographic conditions after getting a stable baseline. Peak area was recorded. The procedure was repeated for thrice. Limit of Detection Detection limit was determined based on the standard deviation of peak areas of same concentrations i.e. Standard solution of Sultamicillin Tosylate Dihydrate (20µglml) prepared six times and LOD calculated by the following formulae. LOD = 3.3(SD/S) Where, SD- Standard deviation; S- Slope of Curve Limit of Quantitation Quantitation limit was determined based on the standard deviation of peak areas of same concentrations i.e. Standard solution of Sultamicillin Tosylate Dihydrate (20µglml) prepared six times and LOQ calculated by the following formulae. LOQ calculated by the following formulae. LOQ = 10(SD/S) Where, SD- Standard deviation; S- Slope of Curve VII. Robustness         The standard solution of (20µg/ml) was prepared and analyzed at different flow rates (0.9, 1.0, 1.1 ml/min) and at different wavelengths (224, 225, and 226). VIII. System Suitability Sample solutions of Sultamicillin Tosylate Dihydrate (50µg/ml) were prepared and analyzed six times. Chromatograms were studied for different parameters such as tailing factor, resolution and theoretical plates to see that whether they comply with the recommended limit or not. Accuracy Recovery study was carried out by standard addition method by adding the known amount of sultamicillin Tosylate dehydrate to preanalysed sample at three different conc. level i.e. 80%, 100%, 120% of assay conc. and percent recovery were calculated. 0.5 ml tablet solution was transferred to 4 different 10ml volumetric flasks (Labelled as blank, 80%, 100%, 120%) separately and 0, 1.6, 2, 2.4ml of 100µg/ml ‘standard solution’ was added respectively and the volume was made up to the mark with mobile phase. and these samples were analysed. RESULTS AND DISCUSSION Determination of wavelength of maximum absorption The wavelength of maximum absorption was found to be 225 nm. Hence HPLC analysis was carried out at 225nm.

Fig 2: Wavelength of maximum absorption of Sultamiciilin Tosylate Specificity

Fig 3: Chromatogram of Sultamicillin Tosylate Dihydrate with degradants               Linearity The linearity of this method was determined at the range from 10-60µg/ml for Sultamicillin Tosylate Dihydrate. The regression equation was found to be Y=8.7304x+5.5409 be, r2=0.9991. Table No-1: Linearity table Sr. No Concentration (µg/ml) Peak Area(mV) 1 10 98.48 2 20 176.48 4 40 349.73 4 50 438.66 5 60 535.84

Fig. 3: Linearity graph of Sultamicillin Tosylate Dihydrate

Fig.4: 0verlain chromatograms of serial dilutions of Sultamicillin Tosylate Dihydrate in optimized chromatographic conditions             The linearity for Sultamicillin Tosylate Dihydrate was found to be linear in the range of 10-60µg/ml with r2= 0.9991 and the straight line equation as Y= 8.7304x+5.5409. 4.4 Range: The range for RP-HPLC method for Sultamicillin Tosylate Dihydrate was found to be 10-60 µg/ml. 4.5 Precision The precision was evaluated as the repeatability of the method and calculated as %RSD values    for six determinations of peak area ratio performed on the same day and under the same experimental condition. 4.5.1 Repeatability Table No-2: Repeatability study for Sultamicillin Tosylate Dihydrate Injection Peak Area of sultamicllin Tosylate Dihydrate (mV) 1 176.47 2 172.61 3 178.99 4 176.28 5 173.81 6 174.41 SD 2.284508 %RSD 1.30 The percentage RSD (˂2) Values obtained shows that the method developed in précised at repeatability. 4.6 Limit of Detection Detection limit is calculated based on standard deviation of response and slope Table No-3: Limit of Detection Data of Sultamicillin Tosylate Dihydrate Sultamicillin Tosylate Dihydrate LOD(µg/ml) 0.02754 4.7 Limit of Quantification Quantification limit is calculated based on standard deviation of response and slope Table No-4: Limit of Quantification data of Sultamicillin Tosylate Dihydrate Sultamicillin Tosylate Dihydrate LOD(µg/ml) 0.08345 4.8 Robustness The robustness was investigated by achieving deliberate changes in flow rate by ±1 units from 1.1 to 0.9ml/min and change in wavelength by ±1nm that flow is at 225nm Robustness of the method was carried out at concentration of 20µg/ml and then T, Rs and N were evaluated. The system suitability parameters remained unaffected over deliberate small change in the chromatoghraphic conditions, illustrating that the method was robust over an acceptable working range of its HPLC operational parameters. Table No-5: Result of Robustness Study: Variation in flow rate and wavelength   Sr no.   Conditions   Range Investigated Retention Time (min) Theorotical Plates(N)   Resolution Tailing Factor(T) 1 Flow Rate (ml/min) 1.1 6.15 7129.9 3.56 1.22 0.9 7.58 8195.1 8.36 1.26 2 Wavelength (nm) 226 6.88 9493.3 7.91 1.25 224 6.85 5013.8 2.138 1.08 System Suitability Testing Study of resolution, tailing factor and capacity factor shows system is suitable for this method Table No-5: Results of System Suitability Parameters Analyte Retention Time (min) Tailing Factor (T) Theoretical Plates (N) Resolution (R) Sultamicillin Tosylate Dihydrate 6.9 1.34 7349.6 7.64 Required limits -- T N > 2000 R >2 Assay of Sultamicillin Tosylate Dihydrate Table No-6: Results of Assay Tablet Formulation Lable claim Amount taken µg Amount found µg Assay% Marzon 375 mg 37 38 102% Accuracy The accuracy study of method was determined through the recovery test of the samples, using known amounts of sultamicillin Tosylate dehydrate reference standard. Table No-7: Results of accuracy of Sultamicillin Tosylate Dihydrate Sr.no Level of % Recovery Amount of Tablet sample solution (ml) Amount of standard drug added (µg/ml) Amount Added µg Amount Found (µg/ml) % Recovery 1 0 0.5 0 0 0 - 2 80 0.5 1.6 16 16.28 101 3 100 0.5 2 20 20.74 103 4 120 0.5 2.4 24 24.75 103     SUMMARY AND CONCLUSION Summary Analytical method development was started with preliminary studies of the Sultamicillin Tosylate Dihydrate according to BP. The drug is freely soluble in methanol. The stock solutions of the drug were prepared in methanol. The RP-HPLC method for estimation of Sultamicillin Tosylate Dihydrate dosage form was developed. The quantification was carried out by using Phenomenex C18 column (150 mm × 4.6 mm, 5 mm) as stationary phase and acetonitrile: water (45:55) as mobile phase. Mobile phase was maintained at a flow rate of 1.0ml/min. The UV detector was operated at 225 nm and  Sultamicillin Tosylate Dihydrate eluted at 6.90 min. The developed RP-HPLC method can be successfully applied for the routine analysis of Sultamicillin Tosylate Dihydrate. Table No-8: Summary of RP-HPLC Method of Sultamicillin Tosylate Dihydrate Sr. No. Parameters Sultamicillin Tosylate Dihydrate 1. Linearity Range (μg/ml) 10-60 2. Regression Equation (y = mx+c) 8.730x+5.540 3. Correlation Coefficient (r2) 0.999 4. LOD (μg/ml) 0.02754 5. LOQ (μg/ml) 0.08345 6. Repeatability (%RSD) 1.06 7. Robustness(%RSD) Flow Rate Wavelength 11.10% 23.94%   Conclusion In conclusion, the proposed HPLC method is simple, accurate, reproducible method for estimation of Sultamicillin Tosylate Dihydrate in bulk and pharmaceutical formulation.  This method shows Assay of Sultamicillin Tosylate Dihydrate within the specified limit. The method shows no interference by the excipients. The statistical parameters and recovery data reveals the good accuracy and precision of the proposed method.  Finally, since no pharmacopoeial method for determination of Sultamicillin Tosylate Dihydrate in bulk and pharmaceutical formulations have been reported yet, the proposed method could be useful and suitable for the estimation of the Sultamicillin Tosylate Dihydrate in bulk and pharmaceutical dosage forms. ACKNOWLEDGEMENT: The authors are grateful to Principal of D.S.T.S. Mandal’s College of pharmacy, Solapur, Maharashtra, India for providing us the research facility. Drug powder was gifted by Associated Biotech and grateful to Mr. Vichitra (Medicef Pharma) REFERENCES Nahler, G. (2009). International Conference on Harmonisation (ICH). In Dictionary of Pharmaceutical Medicine(pp. 96-96). Springer, Vienna. https://doi.org/10.1007/978-3-211-89836-9_719 Sadhana, k., Vasanth, P. M, Ramesh, T, Ramesh Malothu. (2013). Development of New Validated Method for the Determination OF Sultamicillin Tosylate Dihydrate in Tablet Dosage Forms By RP-HPLC. IJPSR, 3(1), 14-16. Kumar, V. J., Gupta, P. B., Kumar, K. P., Ray, U. K., Sreenivasulu, B., Kumar, G. S., & Mukkanti, K. (2011). Identification, isolation and characterization of a new degradation product in sultamicillin drug substance. Journal of pharmaceutical and biomedical analysis, 54(3), 582-587. https://doi.org/10.1016/j.jpba.2010.09.016, PMid:20934824 Japanese Pharmacoepoeia 15 Edition. 1- 1654. https;//en.wikipedia.org/sultamicillin. S. Muvvala, V.N. Rantakaram and R.R. Nadendla. (2012) A Validated RP-HPLC Method for the Estimation of Febuxostat in Bulk Drugs. Int. J. Pharm tech. Res., 4(4), 1352-1366. Lasan V. M, Patel S. A. (2015). Analytical Method Development And Validation for Escitalopran oxalate in pharmaceutical Dosage forms by HPLC Methods. International Journal for Pharmaceutical Research Scholars, 4(1), 19-24. Dinesh Reddy Salla, Vindhyakini dhanthala. (2017). A Validated RP-HPLC Method for Estimation of Rifaximin in its Bulk and Pharmaceutical Dosage forms. International Journal for Pharmaceutical Research Scholars, 6(1), 12-20. S. Potdar, M. S. Kalshetti, R.Y. Patil. (2017). Development and Validation of Novel RP-HPLC for Simultaneous Estimation of Alogliptin Benzoate and Pioglitazone Hcl in Pharmaceutical dosage form. International Journal of Chemical and Pharmaceutical Analysis, 4(3), 1-9. Read the full article

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