1.
J Pharm Biomed Anal. 2013 Dec 12;90C:192-197.
doi:
10.1016/j.jpba.2013.12.002.
Development
and validation of a high performance liquid chromatography assay for the
determination of temocillin in serum of haemodialysis patients.
Miranda
Bastos AC(1), Vandecasteele
SJ(2), Tulkens PM(3), Spinewine
A(4), Van Bambeke F(5).
Author
information:
(1)Pharmacologie
cellulaire et moléculaire, Louvain Drug Research
Institute, Université catholique
de Louvain, Brussels, Belgium; Clinical Pharmacy Research Group, Louvain Drug
Research Institute, Université catholique
de Louvain, Brussels, Belgium; Center for Clinical Pharmacy, Université catholique de Louvain,
Brussels, Belgium.
(2)Department Nephrology and Infectious Diseases, AZ Sint-Jan Brugge-Oostende AV,
Bruges, Belgium.
(3)Pharmacologie
cellulaire et moléculaire, Louvain Drug Research
Institute, Université catholique
de Louvain, Brussels, Belgium; Center for Clinical Pharmacy, Université catholique de Louvain,
Brussels, Belgium.
(4)Clinical
Pharmacy Research Group, Louvain Drug Research Institute, Université
catholique de Louvain, Brussels, Belgium; Center for
Clinical Pharmacy, Université catholique
de Louvain, Brussels, Belgium.
(5)Pharmacologie
cellulaire et moléculaire, Louvain Drug Research
Institute, Université catholique
de Louvain, Brussels, Belgium; Center for Clinical Pharmacy, Université catholique de Louvain,
Brussels, Belgium.
Electronic
address: francoise.vanbambeke@uclouvain.be.
Therapeutic
drug monitoring of β-lactams can be useful for
the optimization of therapy, especially when little reference data exist on
actual pharmacokinetic profiles such as in patients undergoing haemodialysis. There is no reported validated method for temocillin assay in serum samples, and preliminary studies
evidenced potential for interferences by acidic metabolites and co-administered
drugs in patients with advanced kidney failure. This paper describes a fully
validated method for the determination of temocillin
in human serum, and its applicability in haemodialysis
patients. Temocillin was extracted from human serum
by a solid phase extraction methodology, and then assayed by reversed-phase
HPLC with UV-detection. The method was validated according to the accuracy
profile methodology, using total error to verify the trueness, precision and
overall accuracy. It showed high specificity and precision and was accurate in
the concentration range of 5-400mg/L. LOD and LOQ were 1.2 and 5mg/L,
respectively. No interference with 30 co-administered drugs was evidenced. The
method was successfully applied to clinical samples from haemodialysis
patients, showing a high degree of dialysability of temocillin.
Copyright
© 2013 Elsevier B.V. All rights reserved.
PMID:
24389461 [PubMed - as supplied by publisher]