Rogatsky Eduard, Stein Daniel
General Clinical Research Center, Albert Einstein College of Medicine of Yeshiva University, Golding Building Rm. G02, 1300 Morris Park Avenue, Bronx, NY 10461, USA.
J Am Soc Mass Spectrom. 2005 Nov;16(11):1757-9. doi: 10.1016/j.jasms.2005.07.012. Epub 2005 Sep 28.
From the viewpoint of regulatory guidelines, validation of LC-UV and LC-MS based methods have the same requirements. Matrix effects are not considered for most method validations if they do not influence reproducibility or assay linearity. Since matrix effects can strongly suppress ionizaton efficiency and therefore reduce sensitivity, they must be evaluated (and discussed in the context of method development)--prior to method qualification. The severity of matrix effects is directly dependent upon chromatographic performance. We suggest that evaluation of matrix effects and LC efficiency is essential information for method assessment, optimization and transfer to other mass spectrometers, and should be a mandatory part of routine LC/MS method validation.
从监管指南的角度来看，基于液相色谱-紫外检测（LC-UV）和液相色谱-质谱联用（LC-MS）方法的验证有相同的要求。如果基质效应不影响重现性或分析方法的线性，则在大多数方法验证中可不考虑。由于基质效应会强烈抑制电离效率，从而降低灵敏度，因此必须在方法确认之前进行评估（并在方法开发的背景下进行讨论）。基质效应的严重程度直接取决于色谱性能。我们建议，基质效应和液相色谱效率的评估是方法评估、优化以及转移至其他质谱仪的重要信息，并且应该成为常规LC/MS方法验证的一个强制性部分。
