Informatics Publishing Limited

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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