A new validated RP-HPLC-UV DAD method for assay of bisoprolol fumarate and related substances in tablets

Abstract

The research focus of this work was development and validation of an efficient analytical method that can be used for separation and determination of related substances of bisoprolol in finished drug product using reversed-phase HPLC with UV-DAD. In a previous systematic study of various stationary phases and elution conditions it was found that several octadecylsilane phases can be successfully employed for separation of the critical pairs of bisoprolol and its related degradation products. Namely, method development led to conclusions that satisfactory resolution and peak shapes were obtained with gradient elution with water with 0.2% perchloric acid and acetonitrile and the reversed-phase columns: Hypersil 3 BDS C18 (100 x 4 mm, 3 m); Zorbax SB C18 (150 x 4.6 mm, 3.5 m); Acquity UPLC BEH C18 (50 x 2.1 mm, 1.7 m), and Xterra MS C18 (100 x 4.6 mm, 3.5 m). Since regular quality control includes the parameter related substances, which is of great importance for the overall quality of dosage forms, this study was oriented towards widening the available validated analytical methods for determination of this parameter. In this work, the results from the validation of the method for determination of related substances of bisoprolol using Zorbax SB C18 150 x 4.6 mm, 3.5 m, are presented. Validation parameters that were tested (linearity, accuracy, precision, selectivity) confirmed that the method is suitable for its intendance and it was used for characterization of the samples from a forced degradation study of bisoprolol tablets. Keywords: Bisoprolol, RP-HPLC-UV DAD, validation, related substances