Method development and forced degradation studies of carvedilol by RP - HPLC

Abstract

A simple, precise, rapid, accurate, selective and economic high performance liquid chromatographic (RP-HPLC) method has been developed for the estimation of Carvedilol in tablet dosage form. The method development can be achieved by Waters C18, 5mm, 25cmx4.6mm i.d. column was used for the estimation of Carvedilol using Acetonitrile and Phosphate buffer and pH-6.00 can be adjusted with orthophosphoric acid as a mobile phase in the ratio of 60:40 v/v, at ambient temperature and the detector was set at wavelength 242nm.The method was validated for accuracy, precision, robustness and recovery studies. The recovery of the drug was found to be within the limits, relative standard deviation was found to be less than 2% for precession studies. The proposed method for quantitative estimation of Carvedilol was proved by method validation in accordance with the ICH guidelines. Carvedilol is subjected to stress conditions of acid, base, oxidation, and thermal and photolysis. Significant degradation is observed in acid and base stress conditions. The developed method can be successfully applied in the routine analysis of commercial pharmaceutical dosage forms. Degradation pathway for Carvedilol is established as per ICH recommendations by validated and stability-indicating reverse phase liquid chromatographic method.