REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF REGORAFENIB IN TABLET DOSAGE FORM

摘要

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for quantitative determination of Regorafenib in tablet dosage form. In this method Hypersil Gold (C18, 150mmx 4.6mm id, 3u) column with mobile phase consisting of Trifluoroacetic acid (0.2% WV) and Acetonitrile in the ratio of (50: 50 VA/) at 40°C in an isocratic mode was used. The detection was carried out at 260 nm and 20uL injection volume was selected with the flow rate 1mL/min. The linearity range of Regorafenib shows concentration between 5-200 ug/mL. The regression coefficient obtained was 0.999. Retention time of Regorafenib was found to be 6.49 minutes. Acetonitrile and Water in the ratio of (3:1) was used as a diluent. The method was validated as per ICH guidelines and is simple, fast, accurate, precise and can be applied for routine quality control analysis of Regorafenib in tablet dosage form.