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Title of Journal: Anal Bioanal Chem

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Abbravation: Analytical and Bioanalytical Chemistry

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Springer-Verlag

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DOI

10.1002/ange.19500620123

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1618-2650

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Development and inhouse validation of an LCMS/MS

Authors: Kathrin Schmidt Carolin Stachel Petra Gowik
Publish Date: 2008/03/25
Volume: 391, Issue: 4, Pages: 1199-1210
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Abstract

Stilbenes and zeranol are nonsteroidal estrogenic growth promoters which are banned in the European Union EU for use in foodproducing animals by Council Directive 96/22/EC A liquid chromatography–tandem mass spectrometry LCMS/MS method was developed for the screening and confirmation of stilbenes diethylstilbestrol dienestrol hexestrol and resorcylic acid lactones zeranol and its metabolites taleranol and zearalanone as well as the mycotoxins αzearalenol βzearalenol and zearalenone in bovine urine The method permits the confirmation and quantification of stilbenes and resorcylic acid lactones at levels below 1 µg L−1 and 15 µg L−1 respectively The validation was carried out according to Commission Decision 2002/657/EC Chap 313 “alternative validation” by a matrixcomprehensive inhouse validation concept Decision limit CCα detection capability CCβ recovery repeatabiliy withinlaboratory reproducibility and the uncertainty of measurement were calculated Furthermore a factorial effect analysis was carried out to identify factors that have a significant influence on the method Factors considered to be relevant for the method in routine analysis eg operator matrix condition storage duration of the extracts before measurement different cartridge lots hydrolysis conditions were systematically varied on two levels The factorial analysis showed that different cartridge lots storage durations and matrix conditions can exert a relevant influence on the methodThe authors wish to thank Mrs M Grunow and Mr S Zimmermann for their technical assistance in the inhouse validation study Dr Frank Hamann is acknowledged for making available the samples of bovine urine Dr Steffen Uhlig is acknowledged for helpful discussions on statistical issues

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