Tutorial review on validation of liquid chromatography-mass spectrometry methods: part I

Anneli Kruve; Riin Rebane; Karin Kipper; Maarja-Liisa Oldekop; Hanno Evard; Koit Herodes; Pekka Ravio; Ivo Leito

doi:10.1016/j.aca.2015.02.017

Tutorial review on validation of liquid chromatography-mass spectrometry methods: part I

Anal Chim Acta. 2015 Apr 22:870:29-44. doi: 10.1016/j.aca.2015.02.017. Epub 2015 Feb 13.

Authors

Anneli Kruve¹, Riin Rebane¹, Karin Kipper¹, Maarja-Liisa Oldekop¹, Hanno Evard¹, Koit Herodes¹, Pekka Ravio², Ivo Leito¹

Affiliations

¹ University of Tartu, Institute of Chemistry, Ravila 14a, 50411 Tartu, Estonia.
² Finnish Customs Laboratory, Tekniikantie 13, PL 53, FI-02151 Espoo, Finland.

PMID: 25819785
DOI: 10.1016/j.aca.2015.02.017

Abstract

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.

Keywords: Electrospray; Ionization suppression; Limit of detection; Liquid chromatography–mass spectrometry; Robustness; Validation.

Publication types

Review