Analytical method development and validation of teneligliptin hydrobromide in pure form by HPLC

Abstract

A Simple, rapid, sensitive, precise and cost effective High-performance liquid chromatographic (HPLC) method was developed for the Teneligliptin Hydrobromide in pharmaceutical dosage form. The separation was carried out on Protecol C18 ENDURO 250mm×4.6mm ID 5μm 120A column using with mobile phase comprising mixture of Methanol: Buffer (pH 3.5) in the ratio of 72:28 v/v, as the mobile phase at a flow rate 1 ml/min and the detection was carried out using UV-visible detector at 243.5 nm. The method was validated by evaluation of different parameters such as accuracy, precision, linearity, ruggedness, robustness, LOD and LOQ. The retention time were found to be 5.8. Calibration curves were linear with correlation coefficient (r2) 0.998 and concentration range of 10-90 μg/ml. The percentage recovery for Teneligliptin HBr was found to be in the range between 92.08- 100.30. Method was found to be reproducible with relative standard deviation (RSD) for intra and inter day precision less than 2%. The developed methods were validated as per the ICH guidelines.