Abstract A gradient reversed-phase high performance liquid chromatographic method was developed for determining NSC 737664 (2-[(2R)-2-methylpyrrolidin-2-yl]-1H-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 C18 column (150 mm × 4.6 mm, 5 µ). Quantitation was performed using UV detection at 300 nm. Chromatographic peak identity was confirmed using positive-ion electrospray 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.

中文翻译：

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0 期临床试验中血浆和尿液中 NSC 737664（ABT-888：聚（ADP-核糖）聚合酶 (PARP) 的抑制剂）的液相色谱测定

摘要 建立了梯度反相高效液相色谱法测定人血浆中的 NSC 737664 (2-[(2R)-2-methylpyrrolidin-2-yl]-1H-benzimidazole-4-carboxamide; ABT-888)尿。色谱分离使用由 0.1% 甲酸水溶液和 0​​.1% 甲酸乙腈溶液组成的流动相和 C18 柱（150 mm × 4.6 mm，5 µ）。使用紫外检测在 300 nm 处进行定量。使用正离子电喷雾电离质谱法确认色谱峰同一性。该方法被证明是特异性、准确和可重复的，因此适用于监测该药物的血浆和尿液水平，以支持 0 期临床研究。