Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2013 Vol: 5 Issue: 1

Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of linagliptin and metformin in pure and pharmaceutical dosage form

Abstract

A simple, RP-HPLC method was established for determining linagliptin and metformin in pharmaceutical formulations. Linagliptin , metformin and their degradation products were separated using C8 column with Acetonitrile: Water: Methanol (25:50:25 (v/v/v) to pH 4.1 with 0.1% orthophosphoric acid as the mobile phase. Detection was performed at 243 nm using a diode array detector. The method was validated using ICH guidelines and was linear in the range 5-30μg/ and 10-100 μg /ml for linagliptin and metformin respectivily. Good separation of both the analytes and their degradation products was achieved using this method. The developed method can be applied successfully for the determination of linagliptin and metformin.