Stability Indicating HPLC Method Development and Validation for Simultaneous Estimation of Metformin and Empagliflozin in Bulk and Pharmaceutical Dosage Form

Abstract

In the present work, simple, accurate and rapid stability indicating RP-HPLC method has been developed for the simultaneous estimation of Metformin and Empagliflozin in bulk and tablet dosage form. Separation of analytes was carried out on Ascentis C18 HPLC column (4.6 x 150 mm, 5 μm) using a mobile phase of 0.1% orthophosphoric acid and acetonitrile (60:40, v/v), at a flow rate of 1.0mL/min and measurement carried out at UV 260 nm. The validation parameters namely linearity, sensitivity, selectivity, specificity. robustness, precision and accuracy were determined. The peak area response-concentration curve was linear, over the concentration range of 125-750 μg/mL for Metformin and 1.25-7.50 μg/mL for Empagliflozin with quantitation limits of 4.59 μg/mL for Metformin, and 0.08 μg/mL for Empagliflozin. The proposed method was successfully validated for the determination of Metformin and Empagliflozin simultaneously in combined tablet dosage form. The performance of the present method was compared with available RP-HPLC methods and found to be rapid and economical. The proposed stability-indicating RP-HPLC method can be successfully applied to quality control and drug analysis.