Abstract

HPLC METHOD VALIDATION FOR 4-(2,3-EPOXYPROPOXY) CARBOZOLE CONTENT IN CARVEDILOL

Sagar VLN*, Sharma GVR, Omprakash G, Bharat KB

Abstract

High Performance Liquid Chromatography (HPLC) method validation was performed for the determination of 4-(2,3-epoxypropoxy) carbazole content in carvedilol. The validation method utilizes an Inertsil ODS-3V (250X4.6mm), 5μ column at 40 oC, isocratic elution with Buffer: Acetonitrile (50:50) as the mobile phase. The mobilephase flow rate was 1.0 mL min–1. The linearity, range, system precision, method precision, method ruggedness are found to be satisfactory. Therefore the method is assumed to be selective for the determination of 4-(2,3-epoxypropoxy)carbazole content in carvedilol by HPLC. This study showed that 4-(2,3-epoxypropoxy)carbazole peak was well resolved from the other known impurities and carvedilol, the purity angle of 4-(2,3-epoxypropoxy)carbazole is less than the purity threshold and there is no blank interference at the retention time of 4-(2,3-epoxypropoxy)carbazole. Therefore the method is determined to be specific, as judged by resolving 4-(2,3- epoxypropoxy)carbazole content in carvedilol by HPLC.

Keywords: HPLC,Carvedilol,Carbozole.