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Development and validation of a high-performance liquid chromatography assay for posaconazole utilizing solid-phase extraction

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Published/Copyright: October 31, 2008
Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 46 Issue 12

Abstract

Background: Posaconazole is a new broad-spectrum triazole antifungal drug that is used in prophylaxis and therapy of opportunistic fungal infections in immunocompromised patients. Up to now, it is available as an oral suspension only. Due to variable systemic availability known from other azoles, such as itraconazole, it is important to measure blood levels, especially in patients undergoing abdominal surgery which may influence the intestinal resorption.

Methods: A sensitive and selective high-performance liquid chromatography method for the precise determination of posaconazole and the internal standard clotrimazole in human plasma was developed and validated. Samples were extracted using solid-phase extraction and separated on a reversed-phase C8 column (150×4.6 mm, 5 μm) using phosphate buffer (pH 6.7, 0.04 M):acetonitrile:methanol (43:49:8, v/v/v) as mobile phase. UV detection was performed at 260 nm.

Results: This method showed that a lower limit of quantification was 50 ng/mL and the limit of detection 3 ng/mL. Linearity was tested in the range from 50 to 5000 ng/mL (r2=0.9998). Mean recovery was 86%.

Conclusions: The method proved to be a useful tool for therapeutic drug monitoring. It is specific, precise and showed excellent reproducibility as well as a favourable accuracy.

Clin Chem Lab Med 2008;46:1747–51.

Keywords: analytics; antifungal agents; posaconazole; reversed-phase chromatography; solid-phase-extraction
Corresponding author: Dominic Störzinger, Pharmacy Department, University Hospital of Heidelberg, Im Neuenheimer Feld 670, 69120 Heidelberg, Germany Phone: +49-6221-5638119, Fax: +49-6221-565343,
Received: 2008-6-18
Accepted: 2008-8-21
Published Online: 2008-10-31
Published in Print: 2008-12-01

©2008 by Walter de Gruyter Berlin New York

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https://doi.org/10.1515/CCLM.2008.338
Keywords for this article
analytics; antifungal agents; posaconazole; reversed-phase chromatography; solid-phase-extraction

Articles in the same Issue

  1. Editors' and Publisher's Note
  2. CCLM Award for the most cited paper recently published
  3. Reviews
  4. Cystatin C: current position and future prospects
  5. Some heterogeneity factors affecting the B-type natriuretic peptides outcome: a meta-analysis
  6. Genetics and Molecular Diagnostics
  7. Effect of cyclin D1 (CCND1) polymorphism on gastric premalignant condition
  8. Identification of two de novo mutations in Chinese patients with X-linked adrenoleukodystrophy
  9. CYP21A2 gene mutation analysis in Moroccan patients with classic form of 21-hydroxylase deficiency: high regional prevalence of p.Q318X mutation and identification of a novel p.L353R mutation
  10. Apolipoprotein A5 gene −1131T/C polymorphism is associated with the risk of metabolic syndrome in ethnic Chinese in Taiwan
  11. Association of GSTM1 and GSTT1 gene polymorphisms with coronary artery disease in relation to tobacco smoking
  12. Use of the biochip microarray system in detection of myocardial injury caused by radiofrequency catheter ablation
  13. An in-house method for the detection and quantification of HCV in serum samples using a TaqMan assay real time PCR approach
  14. General Clinical Chemistry and Laboratory Medicine
  15. Drugs and brain death diagnostics: determination of drugs capable of inducing EEG zero line
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  28. Does carbamylated hemoglobin still affect the analysis of HbA1c in uremic and hyperglycemic patients?
  29. Recombinant immunoblot for assessment of intrathecally synthesised paraneoplastic antineuronal antibodies in cerebrospinal fluid from patients with paraneoplastic neurological syndromes
  30. Detection of duplicates and redundancies. A major responsibility of peer-reviewers?
  31. Erratum
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  37. Author Index
  38. Author Index
  39. Subject Index
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