Simultaneous spectrophotometric determination of Tipiracil and Trifluridine

Tipiracil and Trifluridine are anticancer drugs used for third or fourth-line treatment of metastatic colorectal cancer. Trifluridine is an active antiviral drug used as ophthalmic solutions for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus type 1 and 2. It's antiviral action is produced by incorporating in to viral DNA during replication, that results in defective proteins formation and increased mutation rate. Tipiracil is approved for the treatment of unresectable advanced or recurrent colorectal cancer in the form of combination drug trifluridine and tipiracil. Tipiracil is a thymidine phosphorylase inhibitor that inhibits degradation of trifluridine, thus increasing systemic exposure to trifluridine. In the present study three new spectrophotometric methods such as Dual wavelength method (Method A), Graphical absorbance ratio method (Method B) and First derivative method (Method C) were proposed for the simultaneous determination of Tipiracil and Trifluridine and phosphate buffer (pH 7.0). Linearity was observed over the concentration range1-80 μg/ml in all the three methods for borate buffer pH 9.0; phosphate buffer pH 7.0 and both the methods were validated as per ICH guidelines. These methods can be successfully applied for the simultaneous determination of Tipiracil and Trifluridine in tablets.