STABILITY INDICATING REVERSE PHASE-HPLC METHOD DEVELOPMENT ANDVALIDATION FOR BELZUTIFAN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

A Simple, sensitive, specific and precise RP-HPLC method for the pharmaceutical dose estimation of Belzutifan. Chromatogram was run through Agilent C18 250 x 4.6 mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 50:50 v/vwas pumped through column at a flow rate of 1.0ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 251nm. Retention time of Belzutifan was found to be 2.351 min. standard %RSD of the Belzutifan were and found to be 0.8. %RSD of Method precision of Belzutifan was found to be 0.2. %Recovery was obtained as 99.64% for Belzutifan. LOD, LOQ values obtained from regression equation of Belzutifan were 0.03, 0.08. Regression equation of Belzutifan is y = 120739x + 6111.9.