Therapeutic drug monitoring of tacrolimus by liquid chromatography-tandem mass spectrometry: Is it truly a routine test?

Taylor, Paul J., Michael E. Franklin, Michael E. Franklin, Tai, Chun-Hui and Pillans, Peter I. (2012) Therapeutic drug monitoring of tacrolimus by liquid chromatography-tandem mass spectrometry: Is it truly a routine test?. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 883-884 108-112. doi:10.1016/j.jchromb.2011.06.024

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Author Taylor, Paul J.
Michael E. Franklin, Michael E. Franklin
Tai, Chun-Hui
Pillans, Peter I.
Title Therapeutic drug monitoring of tacrolimus by liquid chromatography-tandem mass spectrometry: Is it truly a routine test?
Journal name Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences   Check publisher's open access policy
ISSN 1570-0232
1873-376X
Publication date 2012-02
Year available 2011
Sub-type Article (original research)
DOI 10.1016/j.jchromb.2011.06.024
Volume 883-884
Start page 108
End page 112
Total pages 5
Place of publication Amsterdam, Netherlands
Publisher Elsevier
Collection year 2012
Language eng
Formatted abstract
Therapeutic drug monitoring of tacrolimus by high-performance liquid chromatography-tandem mass spectrometry has become standard practice. We report on the long-term (4.5 years) use of one such method. Whole blood samples (25μL) were treated with zinc sulphate (100μL) and acetonitrile containing ascomycin (internal standard, 250μL). A high-performance liquid chromatography-tandem mass spectrometer operating in positive ion mode with an electrospray interface was used. Chromatography was performed on a TDM C 18 cartridge column (10mm×2.1mm, 10μm, Waters) using a switch gradient. A total of 4029 batches were analyzed for tacrolimus; this comprised of 81950 analyses of which 61027 were patient samples. Calibration curves (1.0-50μg/L) were run on 1765 occasions (mean r 2=0.999; range r 2=0.988-0.999). Inter-batch accuracy and imprecision of the method (2.5, 12.5 and 30.0μg/L), when in routine use, was 97.6-98.5% and <8.0%, respectively (n=4031). Evaluation of the method against other methods in an external quality control scheme revealed good agreement by linear regression analysis (y=0.924x+0.196, r 2=0.985). The percentage difference between our results and that of all methods revealed a mean bias of -6.3% and a range of -33.3% to 11.1%. During the evaluation period, four batch failures occurred (0.1% failure rate) and greater than 1000 samples per analytical column was achieved. In conclusion, the described method is ideally suited as a routine test for tacrolimus in the clinical setting.
Keyword HPLC
Tacrolimus
Tandem mass spectrometry
Therapeutic drug monitoring
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Available online 21 June 2011.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2012 Collection
School of Medicine Publications
 
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Created: Thu, 24 Nov 2011, 14:43:11 EST by Matthew Lamb on behalf of School of Medicine