Development and Validation of RP-HPLC Method for Simultaneous Determination of Saroglitazar and DPP4 Inhibitors

Abstract

A modern, highly efficient system of liquid chromatography (RP-HPLC) reversed phase has been developed and validated with a saroglitazar, linagliptin, and teneligliptin photodiode-array (PDA) detector. Phenomenex Luna C-18 column (250 x 4.6 mm, 5 μ) with a combination of the mobile process, phosphate buffer pH 7.0 and acetonitrile with a gradient flow rate of 1.0 mLmin were collected for separation. The detection was conducted for all analytes at 243 nm. The linagliptin, teneligliptin and saroglitazar retention periods were 7.124 minutes, 7.565 minutes and 8.569 minutes respectively. The calibration curve demonstrated strong linearity over the 0.1-0.5 μgmL range. Data collected following system validation revealed that the process built was precise, reliable, linear, accurate and repeatable.