Determinação da segurança biológica do xampu de cetoconazol: Teste de irritação ocular e avaliação do potencial de citotoxicidade in vitro

Abstract

Ketoconazole is an antifungal agent and can be incorporated into several dosage forms, as an example it could be mentioned shampoos and creams. The aim of this work was to assess the biological reactivity in vivo (Draize eye test) and in vitro (cytotoxity test) of ketoconazole in shampoo degradeted under action of light. The formulation was exposed to UV-C (254 nm) radiation and two methods were used for the quantitative determination of ketoconazole: HPLC and microbiological assay. The results showed alteration in ketoconazole in presence of light - secondary peaks in chromatogram and decrease in antifungal activity - however, no alteration on the biological reactivity between ketoconazole shampoo and ketoconazole shampoo containing degradation products was observed.