Development and Validation of Novel RP-HPLC Method for Estimation of Bosentan in Pharmaceutical Dosage Forms

The aim of the present work was to develop and validate a simple, economical, efficient and method for the analysis of Bosentan in pharmaceutical dosage forms by reverse phase high pressure liquid chromatography. A Welchrom C-18 reverse phase column (4.6 x 250 mm, 5 μm). With mobile phase containing 10mM Phosphate Buffer (pH 6.0): Acetonitrile (50: 50, v/v) is used and eluents were monitored at 226nm. The retention time of Bosentan was 3.687min. The method showed a good linearity in the concentration range of 15–27 μg/mL. The validation characteristics included specificity, linearity and limit of detection, limit of quantification, precision, robustness and stability. Validation acceptance criteria were met in all cases. The percent recoveries ranged between 90.7–100 and RSD 0.28%. The method could be successfully used for the analysis of Bosentan in pharmaceutical dosage forms