Abstract

GARCIA PENA, Caridad Margarita et al. Performance assessment of dissolution assay method of 300 mg of Zidovudine tablets produced in Cuba. Rev Cubana Farm [online]. 2010, vol.44, n.3, pp.297-305. ISSN 0034-7515.

A high-performance liquid chromatography method was validated to assess the dissolution of 300 mg Zidovudine tablets manufactured in Cuba with 265 nm ultraviolet (UV) detection. Filtration specificity, linearity, accuracy parameters were assessed. In influence filtration study it was shown that through the line-filter the active principle it isn't absorbed and without filtrate interferences thus it is recommended its use. It was possible to demonstrate the method specificity due to no interferences of the formula excipients in active principle assessment. Linearity curve was drawed in the interval of study concentrations with a correlation coefficient similar to 0.999. The method was precise since the values were within the established limits. Also, we made a statistical comparison of dissolution profiles of tablets manufactured in Cuba versus Retrovir® (leading drug) demonstrating that there is a similarity between the formulas release profile.

Keywords : Zidovudine; validation; dissolution trial.

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