Development and Validation of RP-HPLC Method for the Estimation of Ivabradine in bulk and Pharmaceutical Formations

Abstract

An accurate and stability indicating HPLC method was developed for the estimation of Ivabradine in tablets. The chromatographic analysis was performed on Shimadzu LC-10AT VP system, C18 Column (150 x 4.6mm; 5μ) with mobile phase consisting of acetonitrile: 10Mm ammonium acetate buffer (pH 7.2) in the ratio of 60:40 v/v, at a flow rate of 1.0mL/min and eluents monitored at 285nm. The method was validated for linearity, accuracy, precision, robustness and application for assay as per ICH guidelines. The retention time of ivabradine was 2.224 min. The calibration curves of peak area versus concentration, which was linear from 10 - 50μg/mL for ivabradine, had regression coefficient (r2) greater than 0.999. The method had the requisite accuracy, precision, and robustness for determination of ivabradine in tablets. The proposed method can be successfully employed in routine quality control for the analysis of ivabradine in tablets.