Asian Journal of Pharmaceutical Analysis

Sushil D. Patil ¹, Sunil V. Amurutkar ¹, C. D. Upasani ¹

Affiliations
1 Department of Pharmaceutical Chemistry, SNJB’s (Jain Gurukal) Shriman Sureshdada Jain College of Pharmacy, Neminagar, Chandwad-423101, IN

Abstract

A Stability Indicating RP HPLC method was develop and validated for the determination of Empagliflozin using Phenomenex C₁₈ column (25 cm×4.6 mm, 5μm) with mobile phase consisting of Methanol: Water (70:30% v/v). The flow rate was kept constant 1.0 mL/min and eluent was detected at 224 nm. In calibration curve experiments, Linearity was found to be in concentration range 2-14 μg/mL (R²=0.999) with regression equation Y = 96888x - 25879. Empagliflozin was subject to stress condition including alkaline, acidic, oxidation, wet heat, thermal degradation and photolysis. Empagliflozin is more sensitive towards acid degradation. Also there was no interference of excipient and degradation product at retention time of Empagliflozin, indicating specificity of the method.

Keywords

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

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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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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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