Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Metoprolol Succinate and Chlorthalidone in Bulk and in Tablet Dosage Form

Abstract

RP-HPLC method has been developed along with stability indicating attribute for simultaneous estimation of Metoprolol Succinate and Chlorthalidone in bulk and in tablet dosage form with minimized drug extraction steps. The chromatographic analysis was performed isocratically by using Oyster ODS3, 150 - 4.6 mm column having particle size of 5 µm (Merck) as stationary phase maintained at ambient temperature (about 25 °C) with 1.0 mL/minute of flow rate and 20 mM phosphate buffer having pH 2.3 (adjusted with10% orthophosphoric acid) and Acetonitrile (650:350, v/v) as Eluent at wavelength 225 nm. Individual drug substances as well as combination drug product was subjected to acid, alkali, oxidative, photolytic, thermal and humidity degradation, the peaks due to degraded product were significantly separated out from active analytes peak. The method was validated for the specificity, linearity, detection limit, quantitation limit, precision, accuracy, robustness and solution stability as per ICH guidelines and successfully used for regular analysis.