UV SPECTROPHOTOMETRIC DETERMINATION OF FLUCONAZOLE IN ANTIFUNGAL GEL FOR TOPICAL USE

Abstract

Objective. Development and validation of a method for the quantitative determination of fluconazole in a gel for topical use by UV spectrophotometry for use in routine quality control and expiration dates of the developed dosage form.

Material and methods. The study used the substance of fluconazole (ΧΡΑΝ ΗΛΟZE BIO TECHNOLOGY CO., LTD, China), a standard sample of fluconazole (CAS No.86386-73-4, Sigma-Aldrich), vitamin D3 (CAS 67-97-0), hydroxypropylmethylcellulose (HPMC) (CAS 9004-65-3), benzalkonium chloride (BACH) (CAS 63449-41-2 ), glycerin (LLC Tula Pharmaceutical Factory, Russia), 95% ethyl alcohol (Hippocrates LLC, Russia), model gel samples for external use, manufactured in the laboratory. The quantification of fluconazole was performed on an SF-56 spectrophotometer (Russia).

Results. The developed technique showed high specificity, the linearity of the technique was confirmed in the concentration range of 10-30 micrograms/ml with a correlation coefficient (r) of 0.9992. When determining the precision, the RSD value was 1.54%, which meets the established criteria. The concentration of fluconazole in the gel was determined (0.4890±0.0066%).

Conclusion. The developed UV spectroscopy technique for the determination of fluconazole in gel has shown high specificity and reproducibility. The application of the proposed technique makes it possible to reliably control the content of fluconazole in the gel for topical use, ensuring the quality of the finished dosage form at all stages of production.