Simultaneous quantification of Empagliflozin and Metformin in pharmaceutical dosage form using HPLC technique

Document Type : Original Article

Authors

1 Department of Chemistry, Faculty of science, Benha University.

2 Department of Chemistry, Faculty of science, Zagazig University.

Abstract

A reversed-phase high-performance liquid chromatography (HPLC) method was developed and validated for the simultaneous quantification of empagliflozin and metformin in their combined dosage form. The analysis was performed on an Agilent 1200 system equipped with a diode array detector (DAD) using a Hypersil BDS C18 column (4.6 mm x 15 cm, 5 μm). The mobile phase consisted of an isocratic 70:30 (v/v) mixture of phosphate buffer (prepared by dissolving 6.8 g potassium dihydrogen orthophosphate in 1 L water and filtered with a 0.45 μm nylon filter) and acetonitrile. The flow rate was set to 1.5 mL/min, and the injection volume for both empagliflozin and metformin was 10 μL. Detection was performed at 255 nm using the DAD. The method demonstrated linearity over concentration ranges of 3.125-9.38 μg/mL for empagliflozin (retention time: 6.4 min) and 250-750 μg/mL for metformin (retention time: 2.6 min) with correlation coefficients exceeding 0.999. The relative standard deviation (RSD) was less than 2%. These results demonstrate that the method is rapid, accurate, precise, and sensitive, making it suitable for routine quality control of tablets containing both drugs in pharmaceutical settings

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