Metodologia analítica aplicada ao controle de qualidade do antifúngico cloridrato de butenafina na forma de creme e à avaliação da sua penetração cutânea in vitro / Analytical methodology applied to the quality control of the antifungal butenafine hydrochloride in cream formulation and to the analysis of its penetration in vitro

AUTOR(ES)
FONTE

IBICT - Instituto Brasileiro de Informação em Ciência e Tecnologia

DATA DE PUBLICAÇÃO

2010

RESUMO

Objectives: The aim of the present work was to develop, validate and compare stability indicating methods to quantify butenafine hydrochloride (BTF), raw material and commercial cream, as well as to establish the degradation kinetics of the drug in a stress condition. Also, the study had the goal of validating a method to assess and compare the cutaneous permeation/penetration of two different formulations. Methods: A stability-indicating method for the analysis of BTF by high performance liquid chromatography (HPLC) was developed and validated according to the ICH guidelines. The degradation kinetics of the drug (raw material and cream) under the UVC light was determined. Analyzes to develop and validate an analytical method by capillary electrophoresis, to quantify the drug by itself and in the cream, were performed. The chromatographic method previously developed for the semi-solid product was validated to quantify the drug in porcine skin. Then, the cutaneous permeation/penetration of BTF, through the Franz-type cell, was analyzed to compare two different commercial formulations (one of them is Brazilian and the other is American). Results and Conclusions: The developed stability-indicating method was adequate to determine the active substance in the formulation even in the presence of the degradation products, as well as to quantify the drug in porcine skin and in the receptor fluid. The main extrinsic factors that promote the drug degradation were established: light, oxidative and basic media (the last in the presence of the excipient ingredients). The photodegradation kinetics was determined as first order showing that the process is dependent on the drug concentration, reaffirming the necessity of protection against light. The method by capillary electrophoresis was not specific considering the placebo formulation, hindering its use to the cream. During the cutaneous permeation analysis, no drug was found in the receptor media of both the Brazilian and the American formulations. No difference was verified to the epidermis, although to the dermis there was a statistical distinction as the concentration of retained drug from the American formulation was higher (¿ = 0,05).

ASSUNTO(S)

cloridrato de butenafina butenafine hydrochloride antifungicos high performance liquid chromatography controle de qualidade de medicamentos validation cromatografia liquida de alta eficiencia (clae) stability capillary electrophoresis validação : métodos de análise de fármacos porcine skin estabilidade franz cell eletroforese capilar penetração cutânea

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