title: Tutorial review on validation of liquid chromatography-mass spectrometry methods: part I.
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.
authors.affiliation: University of Tartu, Institute of Chemistry, Ravila 14a, 50411 Tartu, Estonia.
authors.forename: Anneli
authors.initials: A
authors.lastname: Kruve
authors.affiliation: University of Tartu, Institute of Chemistry, Ravila 14a, 50411 Tartu, Estonia.
authors.forename: Riin
authors.initials: R
authors.lastname: Rebane
authors.affiliation: University of Tartu, Institute of Chemistry, Ravila 14a, 50411 Tartu, Estonia.
authors.forename: Karin
authors.initials: K
authors.lastname: Kipper
authors.affiliation: University of Tartu, Institute of Chemistry, Ravila 14a, 50411 Tartu, Estonia.
authors.forename: Maarja-Liisa
authors.initials: ML
authors.lastname: Oldekop
authors.affiliation: University of Tartu, Institute of Chemistry, Ravila 14a, 50411 Tartu, Estonia.
authors.forename: Hanno
authors.initials: H
authors.lastname: Evard
authors.affiliation: University of Tartu, Institute of Chemistry, Ravila 14a, 50411 Tartu, Estonia.
authors.forename: Koit
authors.initials: K
authors.lastname: Herodes
authors.affiliation: Finnish Customs Laboratory, Tekniikantie 13, PL 53, FI-02151 Espoo, Finland.
authors.forename: Pekka
authors.initials: P
authors.lastname: Ravio
authors.affiliation: University of Tartu, Institute of Chemistry, Ravila 14a, 50411 Tartu, Estonia.
authors.forename: Ivo
authors.initials: I
authors.lastname: Leito
keywords: Electrospray; Ionization suppression; Limit of detection; Liquid chromatography–mass spectrometry; Robustness; Validation