HPLC/UV or bioassay: two valid methods for posaconazole quantification in human serum samples

• Published in: Clinical microbiology and infection Vol. 18; no. 12; pp. 1229 - 1235
• Main Authors: Cendejas-Bueno, E., Forastiero, A., Rodriguez-Tudela, J.L., Cuenca-Estrella, M., Gomez-Lopez, A.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Elsevier Ltd 01-12-2012; Blackwell Publishing Ltd; Wiley-Blackwell; Elsevier Limited
• Subjects: Antibiotics. Antiinfectious agents. Antiparasitic agents; Antifungal agents; Antifungal Agents - blood; Bioassay; Biological and medical sciences; Biological Assay - methods; chromatographic method; Chromatography, High Pressure Liquid - methods; Humans; Infectious diseases; Male; Medical sciences; Pharmacology. Drug treatments; posaconazole; Serum - chemistry; Spectrophotometry, Ultraviolet - methods; therapeutic drug monitoring; Triazoles - blood; posaconazole; Bioassay; chromatographic method; therapeutic drug monitoring; Human; Azole derivatives; HPLC chromatography; Method; Infection; Therapeutic drug monitoring; Antifungal agent; Triazole derivatives; Serum; Pharmacokinetics; Posaconazole; Quantitative analysis
• ISSN: 1198-743X; 1469-0691
• DOI: 10.1111/j.1469-0691.2011.03732.x

In this paper we report on the development and validation of two different methods for posaconazole quantification from serum samples, HPLC/UV and bioassay. Both methods have been validated according to international guidelines and were also applied to the analysis of 61 trough serum samples from treated patients. A good correlation between both methods was observed. The HPLC method, more laborious and expensive, was demonstrated to be more accurate, precise and faster (analytical range 0.125-16 μg/mL, accuracy between -2.48 and 3.70% and precision between 2.77 and 5.93%, with an analytical run time of 11 min), making it a valuable tool for reference laboratories that centralize high numbers of samples. The microbiological method, however, is simple and offers sufficient precision and accuracy (analytical range 0.125-16 μg/mL, accuracy between -8.10 and 3.77% and a precision between 4.52 and 10.07%), to be used to monitor posaconazole. It may be a valid alternative to chromatographic methods in clinical laboratories without specialized facilities.