Ultra High Performance Liquid Chromatography Method for the Determination of Two Recently FDA Approved TKIs in Human Plasma Using Diode Array Detection.

摘要: Generally, tyrosine kinase inhibitors have narrow therapeutic window and large interpatient variability compared to intrapatient variability. In order support its drug monitoring, two fast accurate methods were developed for the determination of recently FDA approved anticancer inhibitors, afatinib ibrutinib, in human plasma using ultra high performance liquid chromatography coupled PDA detection. Diclofenac sodium was used as internal standard. The chromatographic separation achieved on an Acquity UPLC BEH C18 analytical column a mobile phase combining ammonium formate buffer acetonitrile at constant flow rate 0.4 mL/min gradient elution mode. A µSPE (solid extraction) procedure, Oasis MCX µElution plates, processed it gave satisfying reproducible results terms extraction yields. Additionally, successfully validated accuracy profiles approach (β = 95% acceptance limits ±15%) over ranges 5–250 ng/mL from 5 400 ng/mL ibrutinib plasma.