Abstract
Erdafitinib is the first treatment targeting susceptible fibroblast growth factor receptor (FGFR) genetic alterations in patients with locally advanced or metastatic urothelial carcinoma. A simple and precise spectrofluorimetric method was developed for its determination depending on fluorescence enhancement using Kolliphor RH 40 micellar medium at pH 10. The fluorescence intensity was measured at 495 nm after excitation at 410 nm. Different experimental parameters affecting the fluorescence intensity, including type of organized medium, diluting solvent, buffer type and pH were studied during optimization phase. Validation according to ICH Q2(R1) guidance was fully fulfilled. The method was linear over the range of 50 – 800 ng/mL. The lower limit of detection (LOD) and lower limit of quantitation (LOQ) were 14.36 and 43.50 ng/mL, respectively. The relative standard deviation values of intraday and interday precisions were less than 1.93 %. The proposed method was successfully applied to laboratory-prepared tablets. Furthermore, the high sensitivity of the method allowed its application on spiked human plasma samples with a high percent of recovery. The greenness of the method was investigated as an Eco-friendly alternative for erdafitinib determination with minimal organic solvent consumption.
Published Version
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