A Novel Analytical Method for Simultaneous Quantification of Bisoprolol and Cilnidipine by Reversed-Phase HPLC in Pure and Tablet Dosage Form

Current study was intended to establish and validate an advanced, novel, stable, simple and systematic analytical procedure to determine Bisoprolol & Cilnidipine in pure drug & tablet by Reversed-Phase HPLC method. The partition of analytes was attained with a combination of reverse phase C18 column (Waters X Terra 150x4.6mm; 3.5µm) and a mobile phase made up of 60% acetonitrile and 40% 0.1% trifluoroacetic acid is utilized, at a flow rate of 1mL/min over an 8minute, isocratic flow and at 225nm isobestic point. With the best acceptable resolution the peaks of Bisoprolol and Cilnidipine was eluted at 3.129min and 6.925min respectively. The linearities of the analytes especially with this proposed method were 2.52 to 37.80µg/ml & 5.00 to 75.00µg/ml for Bisoprolol and Cilnidipine respectively. For the proposed method, all the validation parameters were tested as indicated by ICH guidelines. The %RSD values for system precision was 0.41% for BISO and 0.14% for CILN, %RSD values for method precision was 0.4% for BISO and 0.3% for CILN and %RSD values for intermediate precision was 0.4% for BISO and 0.3% for CILN respectively. As per the validation report, the results of induced degradation studies, stability, precision, accuracy and the remaining validation parameters, however, were all excellent and within the acceptance criteria. The comparative study results reveal that the established process was economic, fast, suitable, sensitive and stable technique for determination of Bisoprolol & Cilnidipine in pure & tablet formulation.