title: Evaluation of matrix effect and chromatography efficiency: new parameters for validation of method development.
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.
authors.affiliation: General Clinical Research Center, Albert Einstein College of Medicine of Yeshiva University, Golding Building Rm. G02, 1300 Morris Park Avenue, Bronx, NY 10461, USA. rogatsky@aecom.yu.edu
authors.forename: Eduard
authors.initials: E
authors.lastname: Rogatsky
authors.forename: Daniel
authors.initials: D
authors.lastname: Stein
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods* / Q000592:standards; D013058:Mass Spectrometry / Q000379:methods*; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013673:Technology Assessment, Biomedical / Q000379:methods*