Development and validation of a high-performance liquid chromatography assay for posaconazole utilizing solid-phase
Dominic Störzinger1, Stefanie Swoboda, Christoph Lichtenstern
1Pharmacy Department, University Hospital of Heidelberg, Heidelberg, Germany. dominic.stoerzinger@med.uni-heidelberg.de
Clinical Chemistry and Laboratory Medicine
|November 1, 2008
Summary
A new high-performance liquid chromatography method accurately measures posaconazole blood levels in immunocompromised patients. This therapeutic drug monitoring is crucial due to variable absorption, especially after abdominal surgery.
Area of Science:
- Analytical Chemistry
- Pharmacology
- Clinical Diagnostics
Background:
- Posaconazole is a broad-spectrum antifungal for immunocompromised patients, available only as an oral suspension.
- Variable systemic availability necessitates blood level monitoring, particularly in post-abdominal surgery patients.
- Intestinal resorption can be significantly influenced by surgical interventions.
Purpose of the Study:
- To develop and validate a sensitive and selective analytical method for posaconazole quantification in human plasma.
- To establish a reliable tool for therapeutic drug monitoring of posaconazole.
Main Methods:
- High-performance liquid chromatography (HPLC) with UV detection at 260 nm.
- Solid-phase extraction for sample preparation.
- Reversed-phase C8 column chromatography using a specific mobile phase composition.
Main Results:
- The method achieved a lower limit of quantification of 50 ng/mL and a limit of detection of 3 ng/mL.
- Linearity was demonstrated in the range of 50–5000 ng/mL (r²=0.9998).
- The mean recovery rate was 86%.
Conclusions:
- The developed HPLC method is a valuable tool for therapeutic drug monitoring of posaconazole.
- The method is specific, precise, reproducible, and accurate.
- Enables effective management of posaconazole therapy in vulnerable patient populations.
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