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A simple, specific, accurate and precise RP-HPLC method has been developed for the simultaneous estimation  of  Tipiracil  and  Trifluridine  in  bulk  &  capsule  dosage  form.  RP-HPLC  method  was developed using Qualisil BDS C-18 (250x4.6mm) 5µm. Linearity was found to be in the range of 6-22 and 3-9 µg/ml for Tipiracil and Trifluridine. Calibration curve showed correlation coefficient of 0.987 and  0.995  for  Tipiracil  and  Trifluridine.  The  percentage  recovery  was  99.17%  and  102.33  % respectively for Tipiracil and Trifluridine indicating accuracy and reliability of method. The method was found to be precise as indicated by the repeatability of the analytical procedure, showing % RSD < 2%. The samples were analyzed using Methanol and Water (55:45 % v/v) as the mobile phase at the flow rate of 1.0 ml/min in gradient mode and detection wavelength is 292 nm. Both the drugs were eluted within 8 minutes and gave sharp peaks with high theoretical plate count and low tailing factor. The retention time for Tipiracil and Trifluridine was found to be 5.037 and 3.627 minutes respectively. The proposed method was validated as per ICH guidelines.


UV – Vis Detector, RP-HPLC method, Tipiracil and Trifluridine.

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How to Cite
Mainaaz, S.H.Rizwan, Khatija Mohammed Bhameshan, Arshiya Sultana. ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF TIPIRACIL AND TRIFLURIDINE IN BULK AND CAPSULE DOSAGE FORM BY RP-HPLC METHOD. Int. j. innov. pharm. sci. res. [Internet]. 2017Sep.15 [cited 2023Mar.27];5(9):32-4. Available from: