Abstract

A stability-indicating HPLC method for related substances has been developed and validated for Metformin Embonate in bulk drug. A gradient RP-HPLC was achieved on a Hypersil BDS C-18 column (250mm×4.6mm i.d., 5 µ) utilizing a mobile phase of acetonitrile and decanesulphonicacid of pH 3.0 and wavelength 230 nm. The Metformin embonate was well resolved from related substances and resolution was more than 2.The stress testing of Metformin embonate was carried out under acidic, alkaline hydrolysis, and oxidation conditions. Metformin embonate was well resolved from its related substances, a main related substance (RS1) and with the resolution ≥2. The proposed method was validated for selectivity, linearity, accuracy, precision and robustness. The method can be used for determination of related substances in Metformin embonate and its application for quality control purpose.