RP-HPLC ANALYSIS METHOD OF BISOPROLOL FUMARATE IN A NEW TABLET FORMULATION
RP-HPLC ANALYSIS METHOD OF BISOPROLOL FUMARATE IN A NEW TABLET FORMULATION (Abstract): Aim: Development of a new HPLC method for the quantitative determination of bisoprolol fumarate in a novel sustained release tablet formulation. Material and methods: The sustained release matrix tablets with bisoprolol fumarate were formulated using an innovative combination of hydroxypropyl methylcellulose and Precirol ATO5 as excipients. The HPLC separation was done using an Agilent Eclipse XDB-C18 column (150 mm ´ 4.6 mm, 5 µm) and a mobile phase consisting of acetonitrile 10 mM and pH 4.5 phosphate buffer solution (10:90, v/v) at a flow rate of 1.0 mL/min. The method was validated according to ICH guidelines in terms of accuracy, precision, linearity and robustness. Results: Bisoprolol fumarate was separated in less than 4 minutes with good resolution and without any tailing effect or excipient interference. The limit of detection and the limit of quantification were 2.79 and 3.07 µg/mL, respectively. The relative standard deviation evaluated for the precision of the method was lower than 1%. Conclusions: The HPLC method developed for the determination of bisoprolol fumarate in a novel sustained release tablet formulation was specific and simple and it could also be used for in vitro studies.
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