Abstract

THE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF VILDAGLIPTIN IN BULK AND TABLET FORMULATION BY USING RP-HPLC

^*Mr. S. Murugesan, Dr. S. K. Senthil Kumar, D. K. Sanjay, K. Sanjay, S. Sanjay,  S. Santhosh Kumar, K. Saranya

Abstract

The present study focuses on the development and validation of a simple, precise, and reliable analytical method for the estimation of vildagliptin in bulk and tablet dosage form using reverse phase high performance liquid chromatography (RP-HPLC). The primary objective of this work was to establish an efficient chromatographic method suitable for routine quality control analysis. Chromatographic separation was achieved using a C18 column with a mobile phase consisting of methanol, formic acid buffer in the ratio of 90:10. The analysis was carried out at a detection wavelength of 267 nm. The optimized conditions provided a well-defined chromatogram with good peak shape and resolution for vildagliptin. The developed method was validated according to ICH guidelines, demonstrating acceptable levels of accuracy, precision, linearity, and specificity. The method showed consistent and reproducible results for the quantification of vildagliptin in both bulk and tablet formulations.

Keywords: VILDAGLIPTIN, HPLC, METHOD DEVOLOPMENT, VALIDATION.