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

BackgroundWe propose a simple, sensitive, and fast high-performance liquid chromatography ultraviolet detection (HPLC-UV) method for the quantitative determination of bosutinib in human plasma. MethodsPlasma samples were processed using an Oasis hydrophilic-lipophilic balance extraction cartridge (1mL, 30mg). Bosutinib and the internal standard imatinibwere 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 250nmx4.6nm i.d., at a flow rate of 1.0mL/min, with ultraviolet detection at 250nm. ResultsThe calibration curve exhibited linearity over the bosutinib concentration range of 25-1500ng/mL at 250nm, with coefficient of variation for intraday precision of 2.42%, 6.04%, and 1.11% for 100, 250, and 1500ng/mL, respectively, of bosutinib. The lower limit of detection was 20ng/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. ConclusionThe proposed HPLC-UV method was successfully applied as an assay to detect bosutinib in human plasma.