A quantitative method for the determination of bosutinib in human plasma using high-performance liquid chromatography and ultraviolet detection

Abstract

Background: We propose a simple, sensitive, and fast high-performance liquid chromatography ultraviolet detection (HPLC-UV) method for the quantitative determination of bosutinib in human plasma. Methods: Plasma samples were processed using an Oasis hydrophilic-lipophilic balance extraction cartridge (1 mL, 30 mg). Bosutinib and the internal standard imatinib were separated using a mobile phase of 0.5% Na2PO4H2O (pH 3.5)-acetonitrile-methanol (55:25:20, v/v/v) on a CAPCELL PAK C18 MG II reversed-phase column 250 nm×4.6 nm i.d., at a flow rate of 1.0 mL/min, with ultraviolet detection at 250 nm. Results: The calibration curve exhibited linearity over the bosutinib concentration range of 25-1500 ng/mL at 250 nm, with coefficient of variation for intraday precision of 2.42%, 6.04%, and 1.11% for 100, 250, and 1500 ng/mL, respectively, of bosutinib. The lower limit of detection was 20 ng/mL. The extraction recovery rates for bosutinib ranged from 84.36% to 85.82%. The intra- and interday precision was below 8.7%, and the accuracy ranged from −5.95% to 5.85% over the linear range. No notable matrix effects or astaticism were observed. Conclusion: The proposed HPLC-UV method was successfully applied as an assay to detect bosutinib in human plasma.