Desenvolvimento e validação de metodologia analítica para avaliação de ebastina comprimidos

• Ano de defesa: 2009
• Autor(a) principal: Arend, Marcela Zart
• Tipo de documento: Dissertação
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade Federal de Santa Maria; BR; Farmácia; UFSM; Programa de Pós-Graduação em Ciências Farmacêuticas
• Palavras-chave em Português: Ebastina; Validação; Quantificação; Dissolução; Estabilidade; Ebastine; Validation; Quantitation; Dissolution; Stability; CNPQ::CIENCIAS DA SAUDE::FARMACIA
• Link de acesso: http://repositorio.ufsm.br/handle/1/5883

Ebastine is a second generation antihistaminic drug used to treat allergic rhinitis and urticaria. It is available in the Brazilian market as tablets and syrup. There are no official methods for ebastine analysis in pharmaceutical formulations. In the present work, methods for quantification and dissolution evaluation of the drug in tablets were developed and validated. Spectrophotometric and liquid chromatographic (LC) methods were used for drug determination. In the spectrophotometric method ebastine can be quantified at 258 nm, using acetonitrile and 0.01M HCl as diluents. The LC analysis were performed on a C18 column maintained at ambient temperature. The mobile phase composed of acetonitrile:phosphoric acid 0.1% pH 3.0 (55:45, v/v), was run at a flow rate of 1.2 mL/min with UV detection at 254 nm. The methods showed good linearity (r>0.999), precision (RSD<2%), and accuracy. The proposed methods were applied for the analysis of pharmaceutical products, showing significant correlation (P>0.05) of the results. The optimization of dissolution test conditions for in vitro quality control of ebastine in tablets was evaluated. The use of 900 mL of 0.01M HCl at 37.0 ± 0.5°C, paddle as apparatus at 75 rpm and 60 minutes of test provided satisfactory results for tested product. The LC method was validated to evaluate dissolution testing and showed to be specific, linear, precise and accurate. The sample tablets containing ebastine were subjected to accelerated stability study under conditions of controlled temperature and relative humidity (40 °C ± 2 °C e 75% ± 5 %, respectively) for six months and then evaluated by LC and mass spectrometry.