Dissertação
Desonida: validação de métodos analíticos e estudo de fotoestabilidade de formulações
Fecha
2013-04-26Registro en:
BRAGA, Muriele Picoli. DESONIDE: VALIDATION OF ANALYTICAL METHOD AND PHOTOSTABILITY STUDY OF FORMULATIONS. 2013. 121 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2013.
Autor
Braga, Muriele Picoli
Institución
Resumen
Desonide is a nonfluorinated corticosteroid with glucorticoid activity. It is used
topically in the treatment of atopic dermatitis, inflammation, pruritus and seborrheic
dermatitis of mild to moderate severity. In Brazil, this drug is available as ointment,
cream, lotion, hair lotion and cream gel. Until now, there are no official methods
focused in the quality control of desonide raw material or its pharmaceutical forms. In
this work, methods were developed and validated by high performance liquid
chromatography (HPLC) for quantitation of desonide in lotion and cream gel.
Furthermore, photostability studies of these formulations were conducted. The HPLC
methods were validated by parameters of linearity, precision, accuracy, robustness
and specificity, which results showed that both methods are stability-indicating.
Chemometric tools were used to study the robustness of the proposed methods
(desonide lotion and cream gel) and also for the optimization of chromatographic
conditions (cream gel). Photostability studies were conducted with an equivalent
procedure, by exposure to UVA radiation (352 nm) portions of the samples for a
period of 48 h. The results showed that both formulations undergo photodegradation,
and the lotion exhibits a degradation rate greater than the cream gel (t90% 1.58 h for
the lotion and 3.65 h for the gel). The study of the kinetics of the reactions indicated
that lotion follows second-order kinetics, while the cream gel follows first order
kinetics.