Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations

The development and validation of a novel, simple, quick HPLC technique for measuring bosentan in pharmaceutical formulations was performed. parameters were tuned to be 1 mL/min flow rate, variable column temperature, mobile phase combination methanol-acetonitrile-water (20:50:30 v/v/v) carry out this study. All measurements carried with UV detector at wavelength 272 nm. Specificity, the limit quantitation (LOQ), detection (LOD), linearity, accuracy, precision, stability, recovery, ruggedness all tested. linear between 0.25 20 µg/mL, precision (RSD%) accuracy (RE%) less than 3.0 2.7%, respectively. LOQ LOD values method 0.1 10 µg/mL standard solution found moderately stable acidic basic settings (0.1 M HCl NaOH) but unstable an oxidative environment (H2O2 solution; 3%). No interference from tablet excipients observed method. approach successfully applied obtained local pharmacy store.