Development and validation of a highly sensitive HPLC-MS/MS method for the QAP14, a novel potential anti-cancer agent, in rat plasma and its application to a pharmacokinetic study

•A HPLC-MS/MS assay for the quantification of QAP14 in rat plasma was established.•Pharmacokinetics of QAP14 was investigated for the first time.•Oral bioavailability of QAP14, an anti-cancer candidate agent, in rat was 50.29 %. QAP14 is a novel anti-cancer compound exhibiting good efficacy and safety in preclinical study. To investigate its pharmacokinetic properties, a rapid and sensitive HPLC-MS/MS method was developed and validated to quantify the concentration of QAP14 in rat plasma. QAP14 was separated on ZORBAX Eclipse XDB-C8 column with a gradient elution. Erlotinib was selected as internal standard and plasma samples were prepared by precipitation with acetonitrile. In the pharmacokinetic study, rats were treated with QAP14 at 2.4 mg/kg (i.v.) or 6 mg/kg (p.o.). This method provided good linearity in the range of 0.5−1000 ng/mL in rat plasma. The accuracy, precision, matrix effect, recovery, stability and carryover fulfilled the criteria. The pharmacokinetic profiles of QAP14 in rats were described by non-compartmental analysis. The oral bioavailability was 50.29 %. The assay is reliable and requires only little sample volume, and the pharmacokinetic properties of QAP14 in rats may provide reference for future studies.