HPLC-UV determination of erdafitinib in mouse plasma and its application to pharmacokinetic studies

Abstract

Erdafitinib is a recently approved fibroblast growth factor receptor (FGFR) inhibitor. It is the first treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer. A simple validated HPLC-UV method was developed for the determination of erdafitinib in mouse plasma. Erdafitinib and internal standard (rivaroxaban) were efficiently separated on Eclipse plus C18 column (4.6 × 100 mm, 3.5 µm). The mobile phase consisted of acetonitrile and 0.01 M ammonium acetate aqueous solution, adjusted to pH 4.4 with acetic acid (26:74, v/v) and it was eluted isocratically at a flow rate of 1.2 mL/min. The UV detection was at 292 nm and the total run time for each sample was 11 min. The method linearity was validated over the range of 0.05–2.00 µg/mL (r2 ≥ 0.9992) and the lower limit of quantification (LLOQ) was 0.05 µg/mL. The within-run and between-run accuracies were 98.56 and 99.24%, respectively while the CV of the method precision did not exceed 6.52%. Plasma samples were extracted using a solid phase extraction procedure and the extraction recoveries were 97.90 ± 4.58%. The method was optimized for the sensitive determination of the studied drug in mouse plasma and was successfully applied to its pharmacokinetic studies.