Development and Validation of a Rapid Reverse Phase High-Performance Liquid Chromatography Method for Quantification of Fluconazole in Pharmaceutical Preparations
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Abstract
Background: Fluconazole is a triazole antifungal agent widely employed in the treat ment of systemic and superficial fungal infections. Accurate, precise, and reliable quantification of the active pharmaceutical ingredient in dosage forms is of critical importance for both quality control and therapeutic efficacy.
Methods: In this study, a reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determina tion of fluconazole in pharmaceutical preparations. Chromatographic separation was performed using a Zorbax C18 column (100 mm × 4.6 mm, 3.5 μm). The mobile phase consisted of a methanol–water mixture (70 : 30, v/v) in an isocratic system at a flow rate of 1.0 mL/min. The injection volume was set at 5 μL, the detection wavelength at 210 nm, and the column temperature at 30°C. The system suitability parameters of the method were found to be within the acceptable limits.
Results: The retention time for fluconazole was determined as 1.13 ± 0.03 minutes. The method demonstrated linearity within the concentration range of 3.0 × 10−7 M to 9.0 × 10−6 M, with a correlation coefficient (r2) of 0.9999. The limit of detection (LOD) and limit of quantification (LOQ) were calculated as 6.0 × 10−8 M and 1.8 × 10−7 M, respectively. Accuracy and precision values were within acceptable ranges for both intra-day and inter-day analyses. Recovery values ranged from 96.2% to 101.3%, while the relative standard deviation values remained below 2%.
Conclusion: The developed RP-HPLC method is a simple, accurate, precise, and robust approach that can be employed for the routine quality control of fluconazolen in pharmaceutical preparations. Moreover, the high sensitivity and reproducibility of the method indicate its potential applicability for the determination of fluconazole in biological samples in future studies.
Cite this article as: Dal Poçan AG. Development and validation of a rapid reverse-phase high-performance liquid chromatography method for quantification of fluconazole in pharmaceutical preparations. Trends in Pharmacy, 2025, 2, 0011, doi: 10.5152/TrendsPharm.2025.25011
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