Stability indicating RP-HPLC method for the simultaneous estimation of ivabradine and metoprolol in bulk and tablet formulation

Abstract

A new, accurate, precise, and robust reverse phase-high-performance liquid chromatography method has been developed along with sensitive stability indicating attributes for the simultaneous estimation of ivabradine (IVA) and metoprolol (MET) in both bulk and tablet formulation. The estimation of the solutes was performed on a Denali C 18 column of dimension 150 mm × 4.6 mm, 5 μm. IVA and MET were eluted with orthophosphoric acid (0.1%) buffer: acetonitrile in the ratio of 60:40 V/V in a 6 minutes isocratic trial at a flow rate of 0.8 ml/minute having an ambient column temperature of 30°C and monitored at 260 nm wavelength. The retention time of IVA and MET was found to be 2.290 and 3.520 minutes, respectively. The Q2b validation of the analytical method revealed good linearity over the concentration range 5-30 μg/ml for IVA and 25-150 μg/ml for MET with r 2 of 0.999 in both the cases. The mean recovery % over the three tested ranges of 50%, 100%, and 150% were found to be 100.46%, 99.68%, and 99.68%, respectively. The acid, alkali, dry heat, and peroxide-induced stress studies presented the formation of a variety of degradation products. The developed analytical method was precise, accurate, and robust for the routine analysis of the drug combination in bulk and tablet formulations.