ISSN : 2663-2187

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Empagliflozin in Bulk Drug and Formulation

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Rajendra D. Dighe1 , Prasanna A. Amrutkar1*, Ganesh B. Sonawane2 , Vinod A. Bairagi3
» doi: 10.48047/AFJBS.6.5.2024. 10887-10902

Abstract

A robust reverse phase high performance liquid chromatographic (RPHPLC) method was developed and validated for the quantification of Empagliflozin in both bulk and formulated forms, with a comprehensive evaluation of its stability under diverse conditions. Effective separation of Empagliflozin and its degradation products was achieved using an Agilent C18 column and a mobile phase comprising methanol and 0.1% formic acid in an equal fraction elution mode at a flow rate of 0.8 mL/min. Detection was carried out using a diode array detector (DAD) at ambient temperature. The method demonstrated linearity over a concentration range of 5-25 µg/mL, with Empagliflozin eluting at 3.4 minutes. The limits of detection (LOD) and quantification (LOQ) were determined to be 0.0509µg/mL and 0.1544µg/mL, respectively. Method validation parameters including precision, accuracy, linearity, selectivity, specificity, and robustness all met the requisite acceptance criteria. Stability-indicating capability was confirmed through subjecting Empagliflozin to various stress conditions, including acidic, alkaline, neutral, photolytic, oxidative, and thermal environments. This validated method ensures reliable and accurate assessment of Empagliflozin, making it suitable for routine analysis and stability testing.

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