Liquid Chromatographic Determination of NSC 737664 (ABT-888: An Inhibitor of Poly(ADP-ribose) Polymerase (PARP)) in Plasma and Urine in a Phase 0 Clinical Trial

摘要

A gradient reversed-phase high performance liquid chromatographic method was developed for determining NSC 737664 (2-[(2R)-2-methylpyrrolidin-2-yl]-lH-benzimidazole-4-carboxamide; ABT-888) in human plasma and urine. The chromatographic separation used a mobile phase composed of 0.1% formic acid in water and 0.1% formic acid in acetonitrile, and a C!8 column (150mm x 4.6mm, Sμ). Quantitation was performed using UV detection at 300 nm. Chromatographic peak identity was confirmed using positive-ion electro-spray ionization mass spectrometry. The method was shown to be specific, accurate, and reproducible, and thereby appropriate for monitoring plasma and urine levels of the agent in support of a phase 0 clinical study.