RP HPLC method development and validation for simultaneous determination of trifluridine and tipiracil in pure and tablet dosage form

Abstract

In this research, Lonsurf Tablets (strength:Trifluridine 20mg and Tipiracil 8.19mg) was investigated for trifluridine and tipiracil content by isocratic RP-HPLC Procedure. Potent separation with reproducible resolution of trifluridine and tipiracil was brought using acetonitrile (35%) and 0.1M dipotassium hydrogen phosphate (65%) at 1.0ml/min rate of flow. 10 µl and 265 nm are the sample injection volume and wavelength set for detection and analysis , respectively. The procedure was validated and favourable linearity of Trifluridine (10 to 30 µg/ml) and Tipiracil (4.095 to 12.285 µg/ml) was achieved with regression coefficient of 0.9999 and 0.9998, respectively. The proposed procedure of RP-HPLC proved to be suitable, rapid, accurate, precise, selective and robust for partition and assessment of Trifluridine and Tipiracil in tablets in quality control labs.