Desenvolvimento e validação de método analítico por CLAE-UV/VIS para determinação do teor e impurezas orgânicas do insumo farmacêutico desloratadina

Abstract

Desloratadine is a metabolic derivative of loratadine, obtained by hydrolytic decarboxylation. It is a long-action antihistamine and is highly selective histamine1-receptor antagonist. Desloratadine is indicated to treat allergic rhinitis symptoms. To prove the safety and efficacy of a drug is necessary to perform a quality control through analytical methods, which will identify and quantify the active pharmaceutical ingredient and its impurities. Thus, the aim of this study was to develop and validate an analytical method by highefficiency liquid chromatography with UV-VIS detection. The method was developed using GL Science Inertsil ODS-3 column in an isocratic system with mobile phase containing a mixture of sodium dodecyl sulfate at a concentration of 0.003 mol L-1 at pH 2.5 and acetonitrile in the proportion 56:44, respectively. The operating conditions were with a flow of 1.0 mL min-1 , an oven temperature of 35 ºC and a run time of 40 minutes. The eluted compounds were monitored at 279 nm. Desloratadine was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Desloratadine was found to degrade significantly in oxidative and stable in acid, base, hydrolytic, thermal and photolytic degradation conditions. The results showed that the analytical method is selective, precise, accurate, robust and linear in the concentration range 64 to 96 µg.mL-1 of desloratadine and in the concentration range 0.04 to 0.21 µg.mL-1 for impurities related. Thus, this method is suitable for the assay determination of desloratadine and for quantify its impurities.