Abstract

Nail lacquers represent new drug form specifically designed to treat infected nail plate. They are complex organic solutions with specific assaying problems due to the high content of the polymer and plasticizer. Furthermore, there is a lack of assaying methods of active substances from this type of formulations in scientific literature. We developed derivative UV-spectrophotometric method for determination of fluconazole content in antifungal nail lacquer formulations. The method was validated for specificity, linearity, precision (repeatability), intermediate precision and accuracy (recovery). The method is specific, linear in the range of 99.53 - 497.65 μg/ml, precise and showed good recovery (98.79% - 101.77% from all six developed formulations). Besides, it is inexpensive, simple and nontoxic, i.e. ecologically acceptable. This method can be used for assaying fluconazole from this type of formulations.

Highlights

  • Onychomycoses, fungal nail infections, are responsible for 50% of all nail disorders [1].Fluconazole is a potent triazole antifungal agent, very effective in treatment of onychomycoses [2,3,4]

  • It is underused in systemic treatment of the disease due to its numerous drug interactions and side-effects [5] as well as heightened susceptibility for development of fungal resistance. These hindrances of fluconazole in systemic therapy of onychomycoses can be solved by its topical use [6]

  • (10% - 40% compared to the polymer). These excipients may interfere with the determination of active substance present in comparatively low concentration

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Summary

Introduction

Fluconazole is a potent triazole antifungal agent, very effective in treatment of onychomycoses [2,3,4] It is underused in systemic treatment of the disease due to its numerous drug interactions and side-effects [5] as well as heightened susceptibility for development of fungal resistance. Nail lacquers (named transungual therapeutic systems) represent new drug forms designed to enable longer release and sustained action of active principle into the infected nail plate. These systems are commonly solutions (or suspensions) containing antifungal agent, film-forming polymer, plasticizer and suitable volatile solvent. These excipients give stable solution (or suspension), spread on nail plate, and after evaporation leave homogenous film

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