Analytical High Performance Liquid Chromatography Method for Estimation of the Bisoprolol Fumarate

Abstract

Introduction: Quality by Design (QbD) guidelines from ICH address pharmaceutical drug ingredient and product research, method development, and validation. Analytical techniques aid QbD application in pharmaceutical development, manufacturing, and quality evaluation. Risk assessment, process monitoring, and analytical testing are crucial steps.Bisoprolol fumarate is a white, crystalline powder used in treating coronary heart disease, hypertension, and chronic stable heart failure. Its molecular formula is C18H31NO4, and its effectiveness in treating myocardial infarction with cardiac insufficiency is being investigated for its impact on cardiac function.

Objectives: This study aimed to enhance the stability indicating chromatographic method and validation parameters for determining Bisoprolol fumarate in the presence of degradation products and impurities, ensuring purity and stability of the bulk drug using HPLC, in compliance with ICH recommendations.

Methods: The central composite design is a popular factorial design in the Response Surface Model (RSM), used to estimate the accurate curvature of the Response Surface. It involves a point at the center and a star point outside the domain.The study examined the impact of mobile phase composition, flow rate, retention time, peak area, theoretical plate number, and peak symmetry on the performance of an analytical method.The mobile phase was created by mixing methanol with water containing orthophosphoric acid, filtering, and sonicating for 10 minutes to ensure thorough mixing and eliminate trapped air bubbles.A 1000 ug/ml standard solution was prepared by dissolving bisoprolol fumarate in methanol, and samples were prepared by dilution to create varying concentrations for analysis.

Results: The HPLC method was validated according to ICH guidelines and was found to be linear, accurate, and precise for Bisoprolol fumarate. The % recovery of Bisoprolol Fumarate was found to be 108.08 %

Conclusions: This study introduces a new, rapid, and sensitive HPLC method for determining bisoprolol fumarate in its pure and dosage forms. It simplifies the extraction process and utilizes cost-effective equipment, solvents, and reagents. This method offers a faster, more efficient, and cost-effective analytical tool for research and pharmaceutical settings.