DEVELOPMENT AND VALIDATION OF RP-HPLC-PDA METHOD FOR THE ESTIMATION OF AMBRISENTAN IN BULK AND TABLET DOSAGE FORMS

A simple and precise RP-HPLC method was developed and validated for the determination of ambrisentan in pharmaceutical dosage forms. Chromatography was carried out on Phenomenex C18 (150 x 4.6mm, 5μm) column using a mobile phase of 10mM ammonium acetate: acetonitrile (65:35% V/V) at a flow rate of 1.0mL/min. The analyte was monitored using UV detector at 262 nm. The retention time was found to be 2.696 minutes. The proposed method was found to be linear in the concentration range of 10-50 μg/mL with a correlation coefficient of 0.999. The mean recoveries obtained for ambrisentan were in the range of 99.24 -99.66%. The developed method has been statistically validated according to ICH guidelines and found to be simple, precise and accurate with the prescribed values. Thus the proposed method was compatible to LC-MS and successfully applied for the estimation of Ambrisentan in routine quality control analysis in bulk and its formulations.