DEVELOPMENT AND VALIDATION OF AN ANALYTICAL METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES IN BISOPROLOL FUMARATE IN DOSAGE FORMS BY HPLC-UV-DAD

Abstract

The aim of this work was the development of an efficient analytical method for the determination of bisoprolol and related substances in the finished drug product using HPLC/DAD. Different bonded phases (alkyl and phenyl) with variable pore sizes and column dimensions, temperatures, and mobile phases with variable pH and additives were tested. Experiments that included using Hypersil 3 BDS C18 100 × 4 mm, 3 μm; Zorbax SB C18 150 × 4.6 mm, 3.5 μm; Acquity UPLC BEH C18 50 × 2.1 mm, 1.7 μm; and Xterra MS C18 100 × 4.6 mm, 3.5 μm gave the best results when considering the separation and resolution of the tested analytes within a reasonable run time. The method using Xterra MS C18 100 × 4.6 mm, 3.5 μm was validated as the most suitable when taking into account the mobile phase preparation and versatility, analysis time, and equipment maintenance.