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Old 05-07-2018, 01:50 PM
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rss In-house validation of a liquid chromatography - tandem mass spectrometry method for

Related Articles In-house validation of a liquid chromatography - tandem mass spectrometry method for the determination of selective androgen receptor modulators (SARMS) in bovine urine.

Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2018 May 04;:

Authors: Schmidt KS, Mankertz J

Abstract
A sensitive and robust liquid chromatography - tandem mass spectrometry (LC-MS/MS) method allowing the rapid screening and confirmation of selective androgen receptor modulators (SARMS) in bovine urine was developed and successfully validated according to Commission Decision 2002/657/EC, chapter 3.1.3 "alternative validation", by applying a matrix-comprehensive in-house validation concept. The confirmation of the analytes in the validation samples was achieved both on the basis of the multiple reaction monitoring (MRM) ion ratios as laid down in Commission Decision 2002/657/EC and by comparison of their EPI spectra with a reference mass spectral library by making use of the QTRAP technology. Here, in addition to the MRM survey scan, enhanced product ion (EPI) spectra were generated in a data-dependent way according to an information-dependent acquisition (IDA) criterion. Moreover, stability studies of the analytes in solution and in matrix according to an isochronous approach proved the stability of the analytes in solution and in matrix for at least the duration of the validation study. To identify factors that have a significant influence on the test method in routine analysis, a factorial effect analysis was performed. To this end, factors considered to be relevant for the method in routine analysis (e.g. operator, storage duration of the extracts before measurement, different cartridge lots and different hydrolysis conditions) were systematically varied on two levels. The examination of the extent to which these factors influence the measurement results of the individual analytes showed that none of the validation factors exerts a significant influence on the measurement results.


PMID: 29727260 [PubMed - as supplied by publisher]



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