Desenvolvimento de método indicativo de estabilidade para detecção de produtos de degradação da associação de zidovudina e lamivudina (300 + 150 mg) em matéria-prima e comprimidos.
Stability can be elucidated as the period to which a proprietary product or raw material alone, remains in accordance with the limits specified over the period of storage and use, with the same conditions and characteristics that had the date of its manufa cture . In order to evaluate the stability of forced degradation test in which the product is subjected to studies provide evidence on how the quality can be varied over time are performed. The method indicative of stability must accurately measure changes in the concentration of active ingredients, without interference from other degradation products, impurities and excipients. The purpose of this study was to develop a stability indicating method, based on the methodology of The United States Pharmacopeia (USP 36) for related substances tablet zidovudine and lamivudine associated through stress tests in alkaline, acidic, neutral and oxidative. The results were analyzed based on the interpretation of the chromatograms generated by High Efficiency Liquid Chr omatography (HPLC) with diode array detector (DAD). Zidovudine was stable in the less concentrated (0.1 to 1.0 M) as raw materials and compressed acidic and basic conditions and in the neutral hydrolysis and oxidative degradation tablet. However proved to be unstable in the severest conditions of acidic and basic hydrolysis (5.0 M), as well as oxidative degradation as raw material. Lamivudine in the form of raw material was stable only in milder conditions (0.1 and 1.0M) and unstable acid hydrolysis in an a lkaline medium (0.1, 1.0 and 5.0 M) and at all concentrations in the oxidative degradation compared to their behavior in the form of tablets, remained stable under mild acidic conditions (0.1 and 1.0) and in alkaline medium (0.1 M) and hydrolysis stable in neutral and alkaline media (1.0 to 5.0 M) acid hydrolysis (5.0 M) and at all concentrations of oxidative degradation. The time of study varied at each condition according to the degree of degradation of each solution producing degradative against assets, since the law calls an extension of degradation of assets between 10 and 30%. According to the results it was found that the method indicative of stability (MIE) can detect degradation products arising from assets that may arise after the stress tests.
Método indicativo de estabilidade, Testes de estresse, Produtos de degradação, ZiIidovudina, Lamivudina
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