Abstract

RODRIGUEZ HERNANDEZ, Yaslenis; SUAREZ PEREZ, Yania; GARCIA PULPEIRO, Oscar  and  RODRIGUEZ BORGES, Tania. Development and validation of a thin-layer chromatography method for stability studies of naproxen. Rev Cubana Farm [online]. 2011, vol.45, n.4, pp. 480-493. ISSN 0034-7515.

The validation of an analytical method was carried out to be applied to the stability studies of the future formulations of naproxen suppositories for infant and adult use. The factors which mostly influenced in the naproxen stability were determined, the major degradation occurred in oxidizing acid medium and by action of light. The possible formation of esters between the free carboxyl group present in naproxen and the glyceryl monoestereate present in the base was identified as one of the degradation paths in the new formulation. The results were satisfactory. A thin-layer chromatography-based method was developed as well as the best chromatographic conditions were selected. GF₂₅₄ silica gel plates and ultraviolet developer at 254 nm were employed. Three solvent systems were evaluated of which A made up of glacial acetic: tetrahydrofurane:toluene (3:9:90 v/v/v)allowed adequate resolution between the analyte and the possible degradation products, with detection limit of 1 µg. The use of the suggested method was restricted to the identification of possible degradation products just for qualitative purposes and not as final test. The method proved to be sensitive and selective enough to be applied for the stated objective, according to the validation results.

Keywords : naproxen; stability; thin-layer chromatography; validation; suppositories.

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