Abstract

DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE ASSAY OF VILDAGLIPTIN

Pragati Ranjan Satpathy*, V. Mohan Goud, Bhoga Bhagya, JVC. Sharma & N.Shyamala

ABSTRACT

A method based on RP-HPLC with indirect UV detection was developed for the determination of Vildagliptin in pharmaceutical dosage form. Vildagliptin is a potent dipeptidyl peptidase IV inhibitor used for treatment of diabetes. Reverse phase separation was obtained within 4 min and was linear in the range of 50–90 μg/mL (r2 = 0.999). Separation was performed on a C18 column using a mixture of pH 8.2 buffer, acetonitrile and methanol as the mobile phase along with indirect UV detection at 254 nm. The retention time was found to be Rt = 3.9 ± 0.1 mins. The validation of this method included determination of its specificity, accuracy, precision, linearity, LOD, LOQ, and robustness. The LOD was 2.98 g/m and The LOQ was 9.94 g/mL for Vildagliptin. The proposed method was successfully applied for the quantitative analysis of VLG in tablet dosage form, which will help to improve quality control and contribute to stability studies of pharmaceutical tablets containing this drug.

Keywords: Vildagliptin, Peptidase IV inhibitor, LOD and LOQ.