Development and validation of a RP-HPLC-PDA method for simultaneous determination of trifluridine and tipiracil in pure and pharmaceutical dosageform

Abstract

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Tipiracil and Trifluridine, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Hypersil C18 (4.6×250mm) 5µ column using a mixture of Acetonitrile: Water:Methanol (60:20:20v/v)as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 230nm. The retention time of the Tipiracil and Trifluridine was 2.8, 3.8±0.02min respectively. The method produce linear responses in the concentration range of 10-50µg/ml of Tipiracil and 66.6-330µg/ml of Trifluridine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.