DEVELOPMENT OF STABILITY-INDICATING UPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF TIPIRACIL ANDTRIFLURIDINE IN FORMULATION

Aim of the present research work was to develop a sensitive, precise, and robust stability-indicating UPLC method for the simultaneous estimation of tipiracil and trifluridine in formulations. The chromatographic separation of a mixture of tipiracil and trifluridine was attained in isocratic method utilizing a mobile phase of 0.1% orthophosphoric acid: acetonitrile in the proportion of 50:50% v/v utilizing a Hibera C18 column which has dimensions of 100 × 2.1 mm, 1.8µ particle size and the flow rate of 1.0 ml/min. The detection system was monitored at 230nm wavelength maximum with 1.5 µl injection volume. The retaining time for trifluridine and tipiracil was achieved at 0.549 min, and 1.251 min. respectively. Tipiracil and trifluridine and their combined drug formulation were exposed to thermal, acidic, oxidative, photolytic, and alkaline conditions. The present method was validated as per the guidelines given by the ICH for specificity, accuracy, sensitivity, linearity, and precision. The developed method was highly sensitive, rapid, precise, and accurate than the earlier reported methods. The total run time was decreased to 3.0 min; hence, the technique was more precise and economical. Stability studies were directed for the suitability of the technique for degradation studies of tipiracil and trifluridine. The projected method can be utilized for routine analysis in the quality control department in pharmaceutical trades.