Abstract

RODRIGUEZ HERNANDEZ, Yaslenis; SUAREZ PEREZ, Yania; GARCIA PULPEIRO, Oscar  and  HERNANDEZ CONTRERAS, Orestes Yuniel. Validation of analytical methods for the quality control of Naproxen suppositories. Rev Cubana Farm [online]. 2011, vol.45, n.3, pp. 341-354. ISSN 0034-7515.

The analysis methods that will be used for the quality control of the future Cuban-made Naproxen suppositories for adults and children were developed for the first time in this paper. One method based on direct ultraviolet spectrophotometry was put forward, which proved to be specific, linear, accurate and precise for the quality control of Naproxen suppositories, taking into account the presence of chromophore groups in their structure. Likewise, the direct semi-aqueous acid-base volumetry method aimed at the quality control of the Naproxen raw material was changed and adapted to the quality control of suppositories. On the basis of the validation process, there was demonstrated the adequate specificity of this method with respect to the formulation components, as well as its linearity, accuracy and precision in 1-3 mg/ml range. The final results were compared and no significant statistical differences among the replicas per each dose were found in both methods; therefore, both may be used in the quality control of Naproxen suppositories.

Keywords : Naproxen; volumetry; ultraviolet spectrophotometry; quality control; validation; suppositories.

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