ABSTRACT

Introduction: A simple specific spectrophotometric method that is accurate, and suitable for the simultaneous determination of Trifluridine and Tipiracil HCl in the combined dosage form. For the treatment of metastatic gastric cancer, a combination of TFD and TP HCl is already in use. Materials and Method: According to ICH guidelines, the simultaneous equation method was used to determine the concentrations of Trifluridine and Tipiracil HCl in the combined dosage form. 0.1 N HCl (pH 1.2) was used as a solvent for the spectrophotometric method development. Results: ?max of Trifluridine and Tipiracil HCl was found to be 262 and 276 nm respectively. Beer’s law was followed over the 5- 30 ?g/ mL concentration ranges for TFD and 2.5-15?g/ mL for TP HCl. The linearity of the proposed methods was tested between 2.5 and 15 ?g/ml for TP HCl and 5 and 30 ?g/ml for TFD. The % assay for the formulation was found to be 99.12±0.002 for TFD and 99.42±0.002 for TP HCl by the methods. The accuracy was observed to be 101%for TFD and 99.9%for TP HCl by simultaneous equation method. LOD and LOQ were 0.61 and 1.87?g/ml for TFD, 1.15?g/ml, and 3.5 ?g/ml for TP HCl.Conclusion: The simultaneous determination of TP HCl, TFD, and pharmaceutical dosage form was successfully accomplished using Vierordt's method, and the resulting results were confirmed to be accurate, quick, and valid. Keywords: Trifluridine; Tipiracil HCl; Vierordt’s Method; Validation, Microsphere
Publication date: 15/06/2023

https://ijbpas.com/pdf/2023/June/MS_IJBPAS_2023_JUNE_SPCL_1050.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.6.1050