Development and validation of RP-HPLC method for the simultaneous estimation of bisoprolol fumarate and telmisartan from pharmaceutical formulations

Abstract

A simple, sensitive, accurate, precise HPLC method developed for the simultaneous estimation of Bisoprolol fumarate and Telmisartan in pharmaceutical dosage forms. Chromatography is carried out at 40ºc temperature on inert sustain C18 Column (4.6 x 150mm, 5µm. particle size) column using a mobile phase of 0.1% of Tri fluroacetic acid in Water: Acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 227nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported in the International Conference on Harmonization guidelines. The retention times for Bisoprolol fumarate and Telmisartan are 2.79min and 3.52min. The linearity range for Bisoprolol fumarate and Telmisartan is 5-25μg/ml and 40-200μg/ml. The % RSD for intra-day and inter-day precision were found to be less than 2 %. The percentage recoveries obtained for Bisoprolol fumarate and Telmisartan ranges from 100.07-100.69% and 99.43-100.60% respectively. Hence the proposed method was found to be accurate, precise, reproducible and specific and can be used for simultaneous analysis of these drugs in tablet formulation.