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Published on: April 23, 2012
Fluconazol method validation by RP-HPLC for determination in biological skin matrices
Alessandra C Ayub1, Cristina D Vianna-Soares, Lucas A M Ferreira
1Laboratório Globo Ltda., Rod. MG424, km 8.8, São José da Lapa, 33350-000, MG, Brazil.
Journal of Chromatographic Science
|June 9, 2007
Summary
This study validates a method for measuring fluconazole (FCZ) in skin samples, crucial for developing topical antifungal treatments and improving patient safety by reducing drug interactions.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Fluconazole (FCZ) is a systemic antifungal for superficial mycoses.
- Adverse reactions and drug interactions affect ~16% of patients.
- FCZ's pharmacokinetic profile favors skin accumulation, making it important for topical treatments.
Purpose of the Study:
- To validate a reversed-phase high-performance liquid chromatography (RP-HPLC) method for quantifying FCZ.
- To assess the method's suitability for biological matrices in topical permeation studies.
Main Methods:
- Method validation using RP-HPLC.
- Testing in simulated FCZ alcoholic solutions applied to skin extracts.
- In vitro permeation studies utilizing Franz cells.
Main Results:
- The validated method operates in the linear range of 2 to 32 microg/mL.
- Good recovery rates (75.0% ± 4.1% to 82.0% ± 6.6%) were achieved for biological matrices.
- The method is suitable for analyzing FCZ in skin extracts after topical application.
Conclusions:
- A validated RP-HPLC method is established for FCZ quantification in biological samples.
- This method supports the development and analysis of topical FCZ formulations for superficial mycoses.
- The validated assay is essential for pharmacokinetic and efficacy studies of topical antifungals.
