Development and validation of a stability indicating assay method for bosentan tablets by RP HPLC

A simple, sensitive, stability - indicating, and precise HPLC method has been developed and validated for the estimation of Bosentan in a commercial tablet dosage form containing 169 mg of Bosentan, with a label claim of 125 mg. The compound and its impuriti es were successfully separated using an isocratic method on a C18 column (X Bridge C18, 3.5 μm, 150 × 4.6 mm), with a mobile phase consisting of trifluoroacetic acid and acetonitrile (50:50, v/v). UV detection was performed at 266 nm, and the flow rate was set at 1.0 mL/min. Various validation parameters, including system suitability, specificity, linearity, accuracy, precision, solution stability, filter interference, and robustness, were thoroughly evaluated to verify the method's reliability. All validat ion parameters were found to fall within the acceptable range, confirming the method's suitability for routine analysis of Bosentan in tablet dosage form. The developed method ensures accurate and precise quantification, demonstrating its potential for use in quality control and stability testing of Bosentan formulations .