Takeo Yasu

Quantification of Plasma Niraparib Using High‐Performance Liquid Chromatography in Patients With Ovarian Cancer

ABSTRACTNiraparib is a small‐molecule inhibitor of poly(adenosine diphosphate [ADP]‐ribose) polymerase 1/2, which is used to treat ovarian cancer. Elevated maximum blood concentrations of niraparib and the area under the blood concentration–time curve (AUC) were correlated with body weight up to 77 kg. Lower body weight increases blood niraparib concentrations and the AUC of ovarian cancer in Asian patients. Therefore, therapeutic drug monitoring (TDM) of ovarian cancer drugs may increase niraparib efficacy and minimize adverse events. In this study, we quantified niraparib in human plasma (50 μL) using a simple and specific HPLC–UV method. The analyte was separated on a reversed‐phase column with an isocratic mobile phase of 0.5% KH2PO4 (pH 4.5) and acetonitrile (75:25, v/v) at a flow rate of 1.0 mL/min. Calibration curves were linear over 0.25–5 μg/mL (r2 = 0.9998). Intraday and interday precision ranged from 2.25% to 6.29% and 1.73% to 3.20%, respectively, whereas accuracy and recovery ranged from −6.02% to −1.75% and > 93.2%, respectively. We cost‐effectively quantified steady‐state niraparib concentrations in the plasma of patients with ovarian cancer. Therefore, our method could be applied to the departments of pharmacy and clinical laboratories in general hospitals to facilitate the TDM of niraparib without the need for LC–MS/MS.