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ISSN 2063-5346
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Stability indicating HPLC method development and validation for estimation of Empagliflozin in bulk and marketed formulation

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Mayuri S. Hande1, Vishal S. More2, Payal S. Gadakh1, Mahesh M. Deshpande1, Shubham S. Ambilwade3, Anagha C. Chitte3, Ajay R. Kotkar3
» doi: 10.48047/ecb/2022.12.10.679

Abstract

Empagliflozin is an oral antidiabetic drug is a selective sodium-glucose transport protein 2 (SGPT2) inhibitor. Stability indicating HPLC assay method was developed and validated for the quantitative determination of empagliflozin in bulk and formulation. An isocratic, RP-HPLC method was developed using YMC C18 5μ (150×4.6) mm column and the mobile phase C and mobile phase D in the ratio of 50:50, where mobile phase C is Ammonium acetate and mobile phase D is ACN: water (80:20). The detection was carried out at a wavelength 224 nm. The Linearity in the method was measured in the concentration range of 100–300 ppm, and the R2 was found to be 0.9991. LOD and LOQ were found to be 3.19 μg/mL and 9.67 μg/mL, respectively. The forced degradation study for drug was done and degradants could be clearly seen. According to ICH and USFDA guidelines, the developed method is validated. The developed HPLC method could be precise, accurate, simple, and rapid for estimating the amount of empagliflozin present in bulk drugs and tablet dosage form. The proposed method can be used for routine analysis in bulk and pharmaceutical formulation due to its high recovery and low relative standard deviation.

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