Volume : 12, Issue : 10, October – 2025
Title:
METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF TRIFLURIDINE AND TIPIRACIL IN PURE FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
Authors :
J. Kalyani * , Dr. Gadipally. Sai Kiran, Dr. D. Venkata Ramana.
Abstract :
A new, simple, Accurate, precise, robust and rugged reverse phase-HPLC method was developed for the simultaneous estimation of the Trifluridine and Tipiracil in pure and pharmaceutical dosage forms. Chromatogram was run through Hypersil C18 (250 mm×4.6 mm, 5μm) particle size. Mobile phase containing Potassium dihydrogen phosphate (0.03M) (pH-2.8): Methanol (75:25%) was pumped through column at a flow rate of 1.0ml/min. Temperature was maintained at Ambient. Optimized wavelength selected was 226 nm. Retention time of Trifluridine and Tipiracil were found to be 1.693min and 3.235min ± 0.02 respectively. The precision %RSD of the Trifluridine and Tipiracil were and found to be 0.435 and 0.039 respectively. %Recovery was obtained as 100.06% and 100.083% for Trifluridine and Tipiracil respectively. Regression equation of Trifluridine is y = 48138x + 5396.0., and y = 71.91x + 42.07 of Tipiracil. The LOD and LOQ values were found to be for the Trifluridine and Tipiracil are 1.27µg/ml, 1.16 µg/ml 3.81µg/ml, 3.48µg/ml and the proposed method was found to be simple, precise, accurate, rapid, economic and reproducible for the estimation of Trifluridine and Tipiracil in pure form and pharmaceutical marketed formulation.
Keywords: Trifluridine and Tipiracil, HPLC, Method Development, Accuracy, Validation.
Cite This Article:
Please cite this article in press J. Kalyani et al., Method Development And Validation For The Quantitative Estimation Of Trifluridine And Tipiracil In Pure Form And Marketed Pharmaceutical Dosage Form By Rp-Hplc , Indo Am. J. P. Sci, 2025; 12(10).
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