RP-HPLC Method Development and Validation for the Estimation of Antidiabetic Drugs Remogliflozin Etabonate and Vildagliptin in Bulk and Pharmaceutical Dosage Form

Abstract

Introduction: The present study was done to develop a rapidand precise method by using reverse-phase high-performance liquid chromatography.
Materials and Methods: This method was developed for the validation of Remogliflozin etabonate and vildagliptin in pharmaceutical dosage forms. Chromatography was carried out on a hypersil C18 (4.6×150 mm, 5 μm) column using a mixture of acetonitrile: Water (50:50% v/v) as mobile phase at a flow rate of 1.0 mL/min. The detection was carried out at 259 nm.
Results: The retention times of remogliflozin etabonate and vildagliptin were found to be 2.344 and 3.282 minutes, respectively. This method produced linear responses in the concentration range of 10 to 50 ppm of remogliflozin etabonate 5 to 25 ppm for vildagliptin. The precision for the determination of assay was below 2.0% RSD.
Discussion: This method can be used in the quality control tests of both bulk and pharmaceutical formulations.