RP-HPLC method for simultaneous estimation of Metformin Hcl, Ramipril and Glimepiride in bulk and their combination tablet dosage form

A simple, accurate, precise assay and rapid stability-indicating reversed phase high performance liquid chromatography (RP-HPLC) method has been developed with an effective resolution and subsequently validated for the simultaneous estimation of Metformin HCl, Ramipril and Glimiperide from their combination drug product. The method was developed using Inertsil ODS C18, 150 x 4.6 mm, L1 packing, maintained at an ambient temperature. The optimum mobile phase used in this method was a mixture of Methanol and pH 3.0 KH2PO4 buffer in the ratio of proportional v/v, flow rate of mobile phase was set 1.0 mL min-1. At 228 nm compounds were eluted and monitored. Metformin HCl, Ramipril and Glimepiride are subjected to stress conditions of acid, base, oxidative, thermal and photolytic degradation. The degradation products were well separated from the main peak proving the stability-indicating ability of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines.[ICHQ2 (R 1)]