An accurate, simple, sensitive and precise stability indicating isocratic, reversed phase liquid chromatographic (RP HPLC) method was developed and validated for the determination of Bosentan in bulk and pharmaceutical dosage form. The separation was achieved on Hypersil ODS C18 (250 mm × 4.6 mm, 5.0μ) column using methanol: acetonitrile: water (60:30:10 v/v/v) as mobile phase at a flow rate of 1 ml/min. Detection wavelength of 225 nm was used.The retention time was found to be 2.38 min and linearity was observed in the concentration range of 1-10 μg/ml with correlation coefficient (R2) of 0.9997. The method was validated as per ICH guidelines for precision, recovery and robustness. Bosentan was subjected to acid and alkaline hydrolysis, oxidation, photochemical and thermal degradation as per ICH guidelines. Method developed was stability indicating. Statistical analysis proves that the method is suitable for the analysis of Bosentan in bulk drug and in pharmaceutical formulations without any interference from the excipients.
