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 mm; Zorbax SB C18 150 × 4.6 mm, 3.5 mm; Acquity UPLC BEH C18 50 × 2.1 mm, 1.7 mm; and Xterra MS C18 100 × 4.6 mm, 3.5 mm 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 mm was validated as the most suitable when taking into account the mobile phase preparation and versatility, analysis time, and equipment maintenance. Validation parameters (linearity, accuracy, precision, selectivity) confirmed the method as suitable for its intended use.

Keywords

• bisoprolol
• related substances
• forced degradation studies