Abstract

The aim of the present study was to develop RP-HPLC-PDA method for the estimation of Macitentan in bulk and pharmaceutical dosage forms. The method uses an Inertsil (250 mm x 4.6, 5 m) with mobile phase consisting ofAcetonitrile: 10 mM Ammonium acetate (60:40 v/v) in an isocratic mode with an injection volume of 10μL and the eluents were monitored at 255 nm. The retention time of Macitentan 5.578 min, it showed linearity in the concentration range of 2-10 μg/mL with a good correlation coefficient of 0.999. The validation parameters like specificity, system suitability, linearity, LOD (0.4042 μg/mL), LOQ (1.225 μg/mL), precision (%RSD >1), robustness were all within the limits stated in ICH guidelines. The developed RP-HPLC-PDA method is specific, accurate, robust and economic, hence it can be successfully applied in routine quality control for the determination of Macitentan in bulk and tablet dosage forms.