VOLUME 18 (Supplement)

Development and validation of an HPLC-PDA method for the quantification of fluconazole and application to fluconazole-loaded buccoadhesive film

Fluconazole is a widely used antifungal drug against Candida infections, including oral candidiasis. To enhance its bioavailability for oral candidiasis management, buccoadhesive dosage forms are being suggested as alternatives to oral dosage forms. This study aimed to develop a simple and reliable high-performance liquid chromatography-photodiode array (HPLC-PDA) method for the detection and quantification of fluconazole in buccoadhesive film formulation. Chromatographic analysis was performed using C18 column (250 mm x 4.6 mm, 5 μm particle size, 100 Å pore size) under isocratic conditions, with mobile phase consisting of water and acetonitrile at a ratio of 75:25. The method used a 10 μL injection volume, a flow rate of 1.20 mL/min, detection at 257 nm under ambient temperature of around 25°C and was run for 6 min. The fluconazole peak appeared at 3.655 ± 0.019 min. The number of theoretical plates was 28238.43 ± 301.34, and the tailing factor was 1.31 ± 0.03, both meeting the acceptable criteria. Method validation confirmed linearity with a coefficient of determination (r²) of 0.9999, good accuracy with a percentage recovery range of 96.28 - 103.57%, and good precision with a percent coefficient of variation below 15%. The acceptable accuracy and precision were also observed when the method was applied in the assay of fluconazole incorporated in buccoadhesive film. Based on the results, the developed HPLC-PDA method proved to be suitable for the detection and quantification of fluconazole in buccoadhesive film formulation.