TY - JOUR
T1 - Evaluation of matrix effect and chromatography efficiency
T2 - New parameters for validation of method development
AU - Rogatsky, Eduard
AU - Stein, Daniel
N1 - Funding Information:
The authors thank Dr. Kevin J. McHale and Dr. Justin Withers for helpful discussions and manuscript review. This work was supported by grants from the National Institutes of Health, 1 R01 DK61644-01, MO1-RR12248, and the American Diabetes Association.
PY - 2005/11
Y1 - 2005/11
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jasms.2005.07.012
DO - 10.1016/j.jasms.2005.07.012
M3 - Article
C2 - 16198119
AN - SCOPUS:26944443099
SN - 1044-0305
VL - 16
SP - 1757
EP - 1759
JO - Journal of the American Society for Mass Spectrometry
JF - Journal of the American Society for Mass Spectrometry
IS - 11
ER -