Asian Journal of Pharmaceutical Analysis

Jayshree Pawar ¹, Sandeep Sonawane ¹, Santosh Chhajed ¹, Sanjay Kshirsagar ¹

Affiliations
1 Department of Pharmaceutical Analysis, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, IN

Abstract

A new, simple and validated RP-HPLC method was developed for simultaneous estimation of MetforminHCl (MET) and Gliclazide (GLZ).The separation was achieved by using mobile phase Methanol: 10 mM Phosphate buffer (pH 3) 70:30 % v/v on Kinetics C₁₈ column (250 x 4.6 mm, 5μ). The flow rate was 1 ml/min. The detection was carried out at wavelength 230 nm.The retention time of MET and GLZ was found to be 2.20 min and 4.67 min, respectively. Calibration curves for MET and GLZ were found to be linear in the range of 10-60 μg/ml and 2-12 μg/ml, respectively. The proposed method was validated as per ICH guideline Q2 (R1). The validation parameters studied were linearity, accuracy, precision, specificity and robustness. All validation parameters were found within the acceptable range.

Keywords

Metformin HCl, Gliclazide, RP-HPLC, Analytical Method Validation.

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Sushil D. Patil ¹, Sayali K. Chaure ¹, Maswood Ahmed Hafizur Rahman ¹, Prajkta U. Varpe ¹, Sanjay Kshirsagar ¹

Affiliations
1 MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra State 422003, IN

Abstract

A rapid, specific and economic UV Spectrophotometric method has been developed using a solvent composed of water: methanol (9.0:1.0) to determine the empagliflozin content in bulk. At a pre-determined λmax of 224 nm, it was proved linear in the range of 1.0-3.0 μg/mL, and exhibited good correlation coefficient (R²=0.998) and minimum sum of square error 0.0595, Hence we have selected equation of line of 50-90% (best fit line) linearity throughout experiment. The method was validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. The obtained results proved that the method can be employed for the routine analysis of empagliflozin in bulks as well as in the commercial formulations.

Keywords

UV, Empagliflozin, Method Development and Validation, ICH Guideline.

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Sushil D. Patil ¹, Sayali K. Chaure ¹, Sanjay Kshirsagar ¹

Affiliations
1 MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, MS 422003, IN

Abstract

A new, simple, accurate and sensitive UV-spectrophotometric absorption correction method has been developed for simultaneous determination of Metformin HCl and Empagliflozin in bulk utilizing concept of standard addition. The method is based upon determination of Empagliflozin at 224 nm & Metformin HCl at 230 nm methanol as a solvent. Overlay spectra of both drugs shows absorbance at 227 nm. Linearity was observed in range of 10-50 μg/ml and 1-3 μg/ml for Metformin HCl and Empagliflozin respectively. The correlation coefficient value was found to near to 1.All methods were statistically validated as per ICH guidelines.

Keywords

Metformin HCl, Empagliflozin, UV-Spectrophotometric, Simultaneous Estimation, Method Development and Validation, ICH Guideline.

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Ashwini Parmar ¹, Sandeep Sonawane ¹, Santosh Chhajed ¹, Sanjay Kshirsagar ¹

Affiliations
1 MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, IN

Abstract

To treat the second stage high blood pressure, physicians prefers the combination drug therapy consisting of two or more anti-hypertensive agents. Among these, telmisartan with amlodipine besylate, telmisartan with hydrochlorthiazide as well as triple drug therapy consisting of amlodipine besylate, telmisartan and hydrochlorthiazide are commonly prescribed. In the present paper, a simple, accurate and precise RP-HPLC method was developed for the estimation of amlodipine besylate, telmisartan and hydrochlorthiazide in bulk and combined dosage form. All these three drugs were successfully separated and resolved from each other on C18 kinetex column (250 × 4.6 mm, 5 μ), using acetonitrile: 20mM phosphate buffer (pH 3.0) (60:40 %, v/v) as a mobile phase at a flow rate of 1 mL/min. The detection was performed at 258 nm. The developed method was further validated as per ICH Q2 (R1) guidelines.

Keywords

Telmisartan, Amlodipine Besylate, Hydrochlorthiazide, RP-HPLC, Analytical Method Validation.

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Kavita Wagh ¹, Sandeep Sonawane ¹, Santosh Chhajad ¹, Sanjay Kshirsagar ¹

Affiliations
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, IN

Abstract

A single, simple, accurate and precise RP-HPLC method has been developed for the estimation of ezetimibe in presence of atorvastatin calcium and simvastatin in bulk and marketed combined formulations. The chromatographic separation was achieved on C18 column (250 × 4.6 mm, 5 μ) using Acetonitrile: water 70:30 v/v as a mobile phase at flow rate of 1.2 mL/min. The separation was achieved in isocratic mode and the detection was performed at 242 nm. Further the developed method was validated as per the ICH Q2 (R1) and applied for quantitation of atorvastatin calcium-ezetimibe and ezetimibe – simvastatin in tablet formulations.

Keywords

Ezetimibe, Simvastatin, Atorvastatin Calcium, RP-HPLC, Analytical Method Validation.

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Ashwini Parmar ¹, Sandeep Sonawane ¹, Santosh Chhajed ¹, Sanjay Kshirsagar ¹

Affiliations
1 MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 42200, IN

Abstract

A simple, accurate and precise RP-HPLC method was developed and validated for simultaneous estimation of glimepiride (GLM) and ezetimibe (EZE) in tablet dosage form. Both drugs were separated on C18 Phenomenex column (250 × 4.6 mm, 5 μ) using methanol: 20mM potassium phosphate buffer (pH 3.00) (80: 20 % v/v) at flow rate of 1 mL/min. All eluents were detected at 230 nm. GLM and EZE were eluted at 5.292 and 4.183 min, respectively. The method was linear in the range of 2-10 μg/mL and 20-100 μg/mL for GLM and EZE, respectively. The developed method was further validated as per ICH Q2(R1) guidelines and applied successfully for the quantitation of tablet dosage form.

Keywords

Ezetimibe and Glimepiride, RP-HPLC, Analytical Method Validation.

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Sushil D. Patil ¹, Prajkta Varpe ², Sayali Chaure ², Sanjay Kshirsagar ²

Affiliations
1 Department of Pharmaceutical Chemistry, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon Nashik, Maharashtra, IN
2 MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra State 422003, IN

Abstract

Comparison Study of conventional and Microwave assisted Force Degradation by using RP- HPLC was carried for determination of Piracetam in film coated tablets. A Grace C18 (250mm x 4.6ID, Particle size: 5 micron)RP- 18 column with a mobile phase consisting of Methanol: Water(20:80v/v) was used. Microwave assisted Force Degradation was performed acid, alkali, wet heat, oxidative and dry heat degradation study to prove that similar degradation product using microwave oven reduced time as compared to conventional. Quantitative evaluation was performed at 205 nm. The HPLC method is selective, precise and accurate and can be used for routine analysis of preparations in pharmaceutical industry quality control laboratories.

Keywords

RP-HPLC, Force Degradation, Microwave and Piracetam.

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