Titre
Validation and long-term evaluation of a modified on-line chiral analytical method for therapeutic drug monitoring of (R,S)-methadone in clinical samples.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Ansermot, N.
Auteure/Auteur
Rudaz, S.
Auteure/Auteur
Brawand-Amey, M.
Auteure/Auteur
Fleury-Souverain, S.
Auteure/Auteur
Veuthey, J.L.
Auteure/Auteur
Eap, C.B.
Auteure/Auteur
Liens vers les personnes
Liens vers les unités
ISSN
1570-0232
Statut éditorial
Publié
Date de publication
2009
Volume
877
Numéro
23
Première page
2301
Dernière page/numéro d’article
2307
Peer-reviewed
Oui
Langue
anglais
Résumé
Matrix effects, which represent an important issue in liquid chromatography coupled to mass spectrometry or tandem mass spectrometry detection, should be closely assessed during method development. In the case of quantitative analysis, the use of stable isotope-labelled internal standard with physico-chemical properties and ionization behaviour similar to the analyte is recommended. In this paper, an example of the choice of a co-eluting deuterated internal standard to compensate for short-term and long-term matrix effect in the case of chiral (R,S)-methadone plasma quantification is reported. The method was fully validated over a concentration range of 5-800 ng/mL for each methadone enantiomer with satisfactory relative bias (-1.0 to 1.0%), repeatability (0.9-4.9%) and intermediate precision (1.4-12.0%). From the results obtained during validation, a control chart process during 52 series of routine analysis was established using both intermediate precision standard deviation and FDA acceptance criteria. The results of routine quality control samples were generally included in the +/-15% variability around the target value and mainly in the two standard deviation interval illustrating the long-term stability of the method. The intermediate precision variability estimated in method validation was found to be coherent with the routine use of the method. During this period, 257 trough concentration and 54 peak concentration plasma samples of patients undergoing (R,S)-methadone treatment were successfully analysed for routine therapeutic drug monitoring.
PID Serval
serval:BIB_0D3A9161914E
PMID
Date de création
2009-07-23T14:11:38.604Z
Date de création dans IRIS
2025-05-20T14:40:37Z