Stability Indicating RP-HPLC Method Development and Validation of Determination of Vildagliptin Tablets

Abstract

Vildagliptin (VLD) is a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the management of type 2 diabetes mellitus. Asimple, sensitive, rapid, precise and accurate reverse phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the determination of Vildagliptin in tablet dosage form. Chromatographic separation was achieved on a

Hypersil BDS C18 (250 × 4.6 mm, 5 µm) column using a mobile phase consisting of Phosphate buffer (pH 3.0): Methanol: Acetonitrile in the ratio of 70:20:10 v/v, at a flow rate of 1.0 mL/min. UV detection was performed at 210 nm with an injection volume of 20 µL. The retention time for Vildagliptin was found to be 4.852 min. The method was validated as per ICH Q2(R1) guidelines for parameters including system suitability, specificity, linearity, precision, accuracy, ruggedness, and robustness. The linearity was established in the concentration range of 25–125 µg/mL for Vildagliptin with a correlation coefficient (r²) of 0.999. The developed method is simple, economical, and reproducible and can be employed for routine quality control analysis of the tablet formulation.

Keywords: Vildagliptin, RP-HPLC, ICH validation, DPP-4 inhibitor, Pharmaceutical formulation.