Calibration; Chromatography, Liquid/methods; Cysteinyldopa/blood; Humans; Limit of Detection; Melanoma/blood; Reference Standards; Reproducibility of Results; Solid Phase Extraction/methods; Tandem Mass Spectrometry/methods; Tumor Markers, Biological/blood
Abstract :
[en] The incidence of malignant melanoma has increased over the past decades, particularly in Caucasian population. This disease presents defavourable prognosis in terms of survey, especially when detection occurs at the metastatic phase. Reliable analytical methods for biomarker determination are thus an interesting tool in pathology detection and follow-up. In this context, a method using SPE-LC-ESI-MS-MS for the determination of 5-S-cysteinyldopa (5-SCD) in human plasma was optimized. The presence of matrix effect was investigated in details while 5-SCD stability was studied according to FDA requirements for the validation of bioanalytical methods. Pre-study and in-study validations of the entire method were then successfully performed by applying the approach based on total measurement error and accuracy profiles over a concentration ranges from 1.6 to 200 ng/ml. Good results with respect to accuracy, trueness and precision were obtained. The maximum risk of observing future measurements falling outside the acceptance limits during routine analysis was also estimated.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Martin, Gaelle
Mansion, François ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Houbart, Virginie ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
PAQUET, Philippe ; Centre Hospitalier Universitaire de Liège - CHU > Dermatologie
RORIVE, Andrée ; Centre Hospitalier Universitaire de Liège - CHU > Oncologie médicale
CHIAP, Patrice ; Centre Hospitalier Universitaire de Liège - CHU > Pharmacologie clinique
Crommen, Jacques ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Servais, Anne-Catherine ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Fillet, Marianne ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Language :
English
Title :
Pre-study and in-study validation of a SPE-LC-MS-MS method for the determination of 5-S-cysteinyldopa, a melanoma biomarker, in human plasma.
Publication date :
2011
Journal title :
Talanta
ISSN :
0039-9140
eISSN :
1873-3573
Publisher :
Elsevier Science, Amsterdam, Netherlands
Volume :
84
Issue :
2
Pages :
280-6
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
Copyright (c) 2011 Elsevier B.V. All rights reserved.
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