期刊
ANALYTICA CHIMICA ACTA
卷 870, 期 -, 页码 29-44出版社
ELSEVIER
DOI: 10.1016/j.aca.2015.02.017
关键词
Liquid chromatography-mass spectrometry; Validation; Electrospray; Ionization suppression; Limit of detection; Robustness
资金
- Estonian Ministry of Education and Research [IUT20-14, PUT34]
- Estonian Science Foundation [8572]
- EU Regional Development Fund [3.2.1201.13-0020]
This is the part I 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 I briefly introduces the principles of operation of LC-MS (emphasizing the aspects important from the validation point of view, in particular the ionization process and ionization suppression/enhancement); reviews the main validation guideline documents and discusses in detail the following performance parameters: selectivity/specificity/identity, ruggedness/robustness, limit of detection, limit of quantification, decision limit and detection capability. With every method performance characteristic its essence and terminology are addressed, the current status of treating it is reviewed and recommendations are given, how to determine it, specifically in the case of LC-MS methods. (C) 2015 Elsevier B.V. All rights reserved.
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