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Niraparib, a PARP Inhibitor which is a novel ovarian cancer drug. For applicability to pharmacokinetic study, a LC-MS/MS based method for monitoring plasma levels of niraparib was developed. The analyte and Olaparib(IS) were chromatographed on YMC Pack ODS column C18 (50×4.6 mm i.d., 3μ) using MeOH:Ammonium Acetate (2 mM) as binary gradient mobile phase at flow rate 1mL/min with splitter (1:1) over 5 min RT. Detection of analytes were performed on LC-MS/MS system in SRM mode. The method was validated over concentration range of 4.38 -1121.35 ng/mL and lower LOQ was 4.38 ng/mL for the analyte. Recoveries from spiked controls were >83% for the analyte and IS at all QC levels. Within batch and between batch accuracy for Niraparib was found within 94.2 -105.8% and 98.9-102.0%. Within batch and between batch precision for niraparib was found <11.2% CV at all concentration levels. This method was successfully applied to monitor PK profile of niraparib on oral and IV administration to rats.

international journal of advances in pharmacy and biotechnology

Development and Validation of Bioanalytical Method for Estimation of Niraparib in Rat Plasma Using High Performance LC-MS/MS And Its Application to Pharmacokinetic Study