Mulvana Daniel E
Advion BioSciences, Ithaca, NY, USA.
Bioanalysis. 2010 Jun;2(6):1051-72. doi: 10.4155/bio.10.60.
The use of LC-MS for bioanalysis of pharmaceuticals is entering its third decade and may be considered to be a mature technology. In many respects this is true, considering the advances made in such areas as instrument performance, electronics, software and automation of use. However, there remain instrumental and noninstrumental areas that require significant attention to ensure data quality. Increasing regulatory focus on analytical method performance and unaddressed method issues require the bioanalyst to understand those areas that most greatly impact data quality. This review will focus on instrumental and noninstrumental areas that can influence data quality, including reference standard and internal standard quality and physicochemical properties, matrix effects, stability in matrix, sample preparation, LC and MS.
液相色谱-质谱联用（LC-MS）技术用于药物生物分析已进入第三个十年，可被视为一项成熟技术。从仪器性能、电子学、软件以及使用自动化等领域取得的进展来看，在很多方面确实如此。然而，仍存在一些仪器和非仪器领域需要给予高度关注，以确保数据质量。监管机构对分析方法性能的关注度不断提高，以及一些未解决的方法问题，都要求生物分析人员了解那些对数据质量影响最大的领域。本综述将聚焦于可能影响数据质量的仪器和非仪器领域，包括参考标准品和内标物的质量及物理化学性质、基质效应、在基质中的稳定性、样品制备、液相色谱和质谱。
