Evaluation of matrix effect and chromatography efficiency: New parameters for validation of method development

Eduard Rogatsky, Daniel T. Stein

Research output: Contribution to journalArticle

71 Citations (Scopus)

Abstract

From the viewpoint of regulatory guidelines, validation of LC-UV and LC-MS based methods have the same requirements. Matrix effects are not considered for most method validations if they do not influence reproducibility or assay linearity. Since matrix effects can strongly suppress ionizaton efficiency and therefore reduce sensitivity, they must be evaluated (and discussed in the context of method development) - prior to method qualification. The severity of matrix effects is directly dependent upon chromatographic performance. We suggest that evaluation of matrix effects and LC efficiency is essential information for method assessment, optimization and transfer to other mass spectrometers, and should be a mandatory part of routine LC/MS method validation.

Original languageEnglish (US)
Pages (from-to)1757-1759
Number of pages3
JournalJournal of the American Society for Mass Spectrometry
Volume16
Issue number11
DOIs
StatePublished - Nov 2005

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Chromatography
Mass spectrometers
Assays
Guidelines

ASJC Scopus subject areas

  • Structural Biology
  • Spectroscopy

Cite this

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