Development and Validation of a Simultaneous HPLC Method for Assay and Dissolution of Bisoprolol Fumarate and Amlodipine Besylate in Pharmaceutical Dosage

A fast and robust RP-HPLC method was developed for simultaneous determination of bisoprolol fumarate and amlodipine besylate in pharmaceutical dosage form. A mixture of buffer prepared by 0.4ml of TEA and 3.12 gm of Sodium dihydrogen orthophosphate in 1000 ml water adjusted to pH 3.0±0.05 and acetonitrile (50:50) was used as mobile phase at 1.0 ml/min flow rate. A widely used stationary phase i.e. C18 column (5, 250×4.6 mm ID) in pharmaceutical industry was selected and UV detection was performed at 230 nm. retention time was obtained as 4.4 minutes and 6.4 minutes for bisoprolol and amlodipine respectively. Linearity was established in the range 1.3g/ml to 10.8g/ml. Correlation coefficients were 0.9999 and 0.9988 for bisoprolol and amlodipine respectively. Mean recoveries were obtained as 99.25% and 99.96% for bisoprolol fumarate and amlodipine besylate respectively.