Stability indicating RP-HPLC method development and validation for simultaneous estimation of cilnidipine and bisprolol fumarate in synthetic mixture

Abstract

A new simple, precise, accurate and selective stability indicating RP-HPLC method has been developed and validated for estimation of Cilnidipine and Bisoprolol fumarate in synthetic mixture. The method was carried out on Hypersil ODS C 5µ column (250 x 4.6 mm) with a mobile phase consisting of Acetonitrile: 0.025 M Dibasic phosphate buffer pH 3.0 with phosphoric acid (70: 30 v/v) and flow rate of 1 mL/min. Detection was carried out at 245 nm. The retention time for Cilnidipine and Bisoprolol fumarate was found to be 3.04 min and 15.114 min, respectively. The Cilnidipine and Bisoprolol fumarate followed linearity in the concentration range of 5 - 25 µg/mL (r= 0.998) and 2.5 - 12.5 µg/mL (r= 0.9993). The developed method was validated for linearity and range, accuracy, precision, and assay. Cilnidipine and Bisoprolol fumarate was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. This indicates that the drug is susceptible to acid, base, oxidation and thermal conditions. The degraded product was well resolved from the pure drug with significantly different Retention time. The proposed method can be used for routine analysis of Cilnidipine and Bisoprolol fumarate in synthetic mixture.