A New Validated RP-HPLC Method for the Estimation of Bosentan in Tablet Dosage Forms

An accurate and precise high performance liquid chromatographic method was developed for quantitative estimation of bosentan in tablet dosage forms. Chromatographic separation of the drug was achieved on a Kromasil C18 column (150 x 4.6 mm; 5µ) by eluting with a mobile phase consisting of phosphate buffer (pH 4.0) and acetonitrile (30:70 v/v) at a flow rate of 1.0 mL/min. The drug in the eluate was monitored by U V detection at 270 nm. The retention time obtained for the drug was 3.54 min. The calibration curve plotted was linear over the range of 25-175 µg/mL of the drug. The validation of the method was done following the ICH guidelines. The proposed method could be applied for determination of bosentan in its tablet dosage forms without any interference from excipients. The method is suitable for routine quality control analysis of bosentan formulations.