Abstract

A Stability Indicating Assay Method For Captopril Tablets By High Performance Liquid Chromatography For Stability Studies

Author(s): Monika Jain, S.N.Shrivastava

A simple and stability indicating HPLC assay procedure had been developed and validated for captopril tablets stability samples. The HPLC conditions were as follows, column: Luna C8, 5μm packing, 4.6 mm x 250 mm: UV at 220 nm: injection volume:20 μl: mobile phase water : acetonitrile : tetrahydrofuran :methane sulfonic acid in the ratio of (80:10:10:0.1);isocratic elution under ambient condition at flow rate of 1.0 ml min1. The procedure separated captopril and potential degradation product captopril disulphide. The retention time of captopril is 6.4 min and asymmetry of 0.99. Whereas pharmacopical and various available methods shows captopril around 3.0 min(dead volume) and asymmetry about 2.0. The instrument precision obtained was 0.61 %.The procedure provided a linear response in the range of 25 – 75 μg/ml (r = 1.000). Forced degradation study shows, response of main drug is reduced in acid, alkali and peroxide degradation. The method was validated for accuracy, robustness and solution stability was obtained up to 19 hrs.