Abstract

RODRIGUEZ HERNANDEZ, Yaslenis et al. Validation of analytical methods for the stability studies of naproxen suppositories for infant and adult use. Rev Cubana Farm [online]. 2011, vol.45, n.4, pp. 494-504. ISSN 0034-7515.

Analytical and validating studies were performed in this paper, with a view to using them in the stability studies of the future formulations of naproxen suppositories for children and adults. The most influential factors in the naproxen stability were determined, that is, the major degradation occurred in acid medium, oxidative medium and by light action. One high-performance liquid chromatography-based method was evaluated, which proved to be adequate to quantify naproxen in suppositories and was selective against degradation products. The quantification limit was 3,480 µg, so it was valid for these studies. Additionally, the parameters specificity for stability, detection and quantification limits were evaluated for the direct semi-aqueous acid-base method, which was formerly validated for the quality control and showed satisfactory results. Nevertheless, the volumetric methods were not regarded as stability indicators; therefore, this method will be used along with the chromatographic methods of choice, that is, thin-layer chromatography and high-performance liquid chromatography, to determine the degradation products.

Keywords : naproxen; stability; volumetry; high-performance liquid resolution; validation; suppositories.

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