RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF REMOGLIFLOZIN ETABONATE, VILDAGLIPTIN AND METFORMIN HYDROCHLORIDE

Abstract

The present study aimed to advance a reliable and efficient RP-High-Performance Liquid Chromatography method for the simultaneous determination of Remogliflozin Etabonate, Vildagliptin, and Metformin Hydrochloride in both bulk drug samples and combined pharmaceutical formulations. Another objective was to indorse the developed analytical method for its applicability in routine quality control testing. Methodology: Analysis by Chromatography was carried out using a Waters C-18 extended column (250 mm × 4.6 mm, 5 µm) as the stationary phase. The mobile phase consisted of Acetonitrile and Trifluoroacetic Acid buffer (pH 2.0) in the ratio of 65:35 (v/v). Prior to use, the mobile phase was degassed by sonication for 10 minutes and filtered through a 0.45 µm membrane filter. The separation was executed at a flow rate of 1.0 mL/min, while the temperature of the column was sustained at 25 ± 1°C. Detection of analytes was achieved using an Ultra Violet detector set at a wavelength of 215 nm. Results: Under optimized chromatographic conditions, Metformin Hydrochloride, Vildagliptin, and Remogliflozin Etabonate were eluted at retention time of 2.05 min, 3.007 min, and 5.290 min, respectively, demonstrating effective separation of the three compounds. Conclusion: The RP-HPLC method proposed was successfully validated using as per the ICH recommendations. Linearity, accuracy, precision, specificity and robustness of validation were within acceptable limits. The developed method was rapid, precise, and reproducible and was observed suitable for routine measureable assay of Remogliflozin Etabonate, Vildagliptin and Metformin Hydrochloride in pure and dosage form.