METHOD DEVELOPMENT AND VALIDATION OF CAPECITABINE IN TABLETS BY RP-HPLC METHOD

An isocratic reverse phase liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the determination of Capecitabine in Bulk and its pharmaceutical formulation. Separation was achieved with a Develosil (ODS-MG-5; 100 x 4.6mm I.D; particle size 5 μm) Column and buffer Methanol (450:550) v/v as eluent and purified water, methanol and acetonitrile(600:350:50)v/v as diluent at flow rate 1.0 mL/min and the Column temperature was 40°C. The described method of Capecitabine is linear over a range of 6 μg/mL to 30 μg/mL. The method precision for the determination of assay was below 2.0% RSD. Key words: Capecitabine, RP-HPLC, Develosil ODS-MG-5.