RP- HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TIPIRACIL AND TRIFLURIDINE IN TABLET DOSAGE FORM

A simple, Accurate, precise method was developed for the simultaneous estimation of the Tipiracil and Trifluridinein Tablet dosage form. Chromatogram was run through C18Hypertsil 5µ, 250mm×4.6mm column using 0.1% ortho phosphoric acid in water: acetonitrile (pH 4 using sodium hydroxide) as mobile phase. The retention time for Lamivudine and Tipiracil and Trifluridinewere 2.1 min and 4.2 min respectively. The method is linear over a concentration range of 22.5 – 135 µg/ml for Tipiracil and 50 to 300 µg/ml for Trifluridine. The method wwas precise with % RSD within the acceptance limits.The method was validated for system suitability, accuracy, precision, linearity and ruggedness. The system suitability parameters were within limit, hence it was concluded that the method was suitable to perform the assay.. Keywords: Tipiracil, Trifliridine, RP- HPLC, Simultaneous estimation, Method validation.