REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF BEXAROTENE IN CAPSULE DOSAGE FORM

摘要

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic method has been developed for quantitative determination of antineoplastic drug bexarotene and its capsule formulation. In this method Synchronis (C18, 25cmx4.6mm id , 5u) column with mobile phase consisting of buffer (25mM ammonium acetate wA/ solution adjusted to pH 4.0 with diluted acetic acid) and acetonitrile in the ratio of (20: 80 VA/) in an isocratic mode was used. The detection was carried out at 262 nm and 20.0 uL injection volume was selected, with the flow rate of 1.0 mL/min being used. The linearity range of bexarotene shows concentration between 5-200 ug/mL. Retention time of bexarotene was found to be 12.58 minutes. Mobile phase itself 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 bexarotene in its formulation.