Kruve Anneli, Rebane Riin, Kipper Karin, Oldekop Maarja-Liisa, Evard Hanno, Herodes Koit, Ravio Pekka, Leito Ivo
University of Tartu, Institute of Chemistry, Ravila 14a, 50411 Tartu, Estonia.
Finnish Customs Laboratory, Tekniikantie 13, PL 53, FI-02151 Espoo, Finland.
Anal Chim Acta. 2015 Apr 22;870:8-28. doi: 10.1016/j.aca.2015.02.016. Epub 2015 Feb 13.
This is the part II of a tutorial review intending to give an overview of the state of the art of method validation in liquid chromatography mass spectrometry (LC-MS) and discuss specific issues that arise with MS (and MS-MS) detection in LC (as opposed to the "conventional" detectors). The Part II starts with briefly introducing the main quantitation methods and then addresses the performance related to quantification: linearity of signal, sensitivity, precision, trueness, accuracy, stability and measurement uncertainty. The last section is devoted to practical considerations in validation. With every performance characteristic its essence and terminology are addressed, the current status of treating it is reviewed and recommendations are given, how to handle it, specifically in the case of LC-MS methods.
这是一篇教程综述的第二部分，旨在概述液相色谱-质谱联用（LC-MS）方法验证的最新技术水平，并讨论液相色谱中使用质谱（和串联质谱）检测（与“传统”检测器相对）时出现的具体问题。第二部分首先简要介绍主要定量方法，然后阐述与定量相关的性能：信号线性、灵敏度、精密度、真实性、准确度、稳定性和测量不确定度。最后一部分专门讨论验证中的实际考虑因素。针对每一项性能特征，阐述其本质和术语，回顾其处理现状，并给出在LC-MS方法中如何具体处理的建议。
