Tutorial review on validation of liquid chromatography–mass spectrometry methods: Part II

•The status of validation of LC–MS methods is comprehensively reviewed.•Clarity is brought into validation-related terminology.•Recommendations on difficult validation-related issues in LC–MS are given.

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.

Graphical abstractFigure optionsDownload full-size imageDownload as PowerPoint slide