1. J Pharm Biomed Anal. 2014 Mar;90:192-7. doi: 10.1016/j.jpba.2013.12.002. Epub
2013 Dec 12.

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 5-400 mg/L. LOD and LOQ were 1.2 and 5 mg/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 - in process]