期刊
BIOMEDICAL CHROMATOGRAPHY
卷 24, 期 1, 页码 2-19出版社
WILEY
DOI: 10.1002/bmc.1373
关键词
LC-MS/MS bicianalytical method development; incurred sample; metabolite interference; phospholipids matrix effect; phospholipids removal by extraction; chromatographic separation of phospholipids from analyte; LC column and mobile phase optimization; UPLC versus HPLC
This treatise summarizes the underlying principle and the road map for systematic LC-MS/MS bioanalytical method development. The three themes that have recently emerged as central to building quality during method development-phospholipids, incurred sample and sound chromatographic considerations-are the main focus of this article. In order to reduce the bioanalytical risk associated with plasma phospholipids, a dual approach involving extraction and chromatography is recommended. The use of incurred sample during method development is essential to avoid interference arising from drug-related components. This is different from the current practice of incurred sample reanalysis, which tests reproducibility during method application. LC column/mobile phase optimization is needed to achieve appropriate peak shape, sensitivity and the separation of the analyte from interfering metabolites and phospholipids. Related to sound chromatographic considerations, we lay out facts and myths related to LIPLC, vis-h-vis HPLC. Incorporation of quality during method development avoids the costly experience of finding out by chance about the invalidity of a method after it has been used in support of a number of pivotal clinical and non-clinical studies. To this end, we put forth an outline of a protocol for a systematic LC-MS/MS bioanalytical method development. Copyright (C) 2010 John Wiley & Sons, Ltd.
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