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ISSN 2063-5346
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Method Development, Validation and Forced Degradation Studies of Empagliflozin and Metformin in Combined Dosage Forms by RP-HPLC

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Ms. Anamika Singh, Dr. Tamanna Narsinghani
» doi: 10.31838/ecb/2023.12.si4.296

Abstract

A simple, sensitive, robust, precise, and efficient RP-HPLC approach for the simultaneous determination of Empagliflozin and Metformin in combination. As per ICH Q2 (R1) guidelines, the final chromatographic conditions were optimized with a mobile phase ratio of (30:70% v/v) in Water containing 0.1% formic acid: Methanol containing 0.1% formic acid at a flow rate of 1 mL/min, column temperature of 35°C, injection volume of 20 µL, Interstil C18 analytical column. Empagliflozin and Metformin reported retention times of 1.73 min and 2.35 min, respectively. Validation of a method was found to be linear in the range of 0.5-1.5 µg/ml for Empagliflozin and 0.63-1.88 µg/mL for Metformin. The % Recovery for Empagliflozin was discovered to be 99.913-100.718%, while for Metformin, it was found to be 99.964-100.188%. The Precision results for both drugs were within the limits while expressed Intraday and Interday. For Empagliflozin, the LOD and LOQ were reported to be 0.106 µg/mL and 0.323 µg/mL, respectively, and for Metformin, 0.129 µg/mL and 0.389 µg/mL. As per ICH Q1A (R2) guidelines, the combination was subjected to acid, base, oxidation, thermal, and photolysis stress conditions.

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