Rajkiran Kolakota*, P. Anil Naidu, Uha Rani Duppala
Department of Pharmaceutical Analysis, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP
A B S T R A C T
A simple and reproducible method was developed for Vildagliptin by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Vildagliptin was separated on Altima C18 column (150 x 4.6mm, 5μm), using Phosphate buffer: ACN (72:28, v/v), pH-2.6 at the UV detection of 266nm. Isocratic elution of acetonitrile (ACN) and buffer was used as a mobile phase with various ratios and flow rates, eventually Phosphate buffer: ACN (72:28, v/v), pH-2.6 was being set with the flow rate of 1 mL/min. The statistical validation parameters such as linearity, accuracy, precision, inter-day and intra-day variation were checked, further the limit of detection and limit of quantification of Vildagliptin concentrations were found to be 0.081 and 0.245 µg/mL. Recovery and assay studies of Vildagliptin were within 98.5 to 100.93 % indicating that the proposed method can be adoptable for quality control analysis of Vildagliptin.
Keywords: RP-HPLC, Validation, Vildagliptin, acetonitrile