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Revista Cubana de Farmacia
versión On-line ISSN 1561-2988
Resumen
PORTO VERDECIA, Marlene; DE LA PAZ FERREIRO, Belkis y GARCIA DIAZ, Nuria. Determinación de atropina sulfato y difenoxilato clorhidrato en reasec tabletas.: Validación. Rev Cubana Farm [online]. 2001, vol.35, n.2, pp. 95-99. ISSN 1561-2988.
Reasec is an antidiarrheal whose effect lies in the association of two active principles: atropine sulphate and diphenoxilate chlorhydrate. Their union results in the inhibition of peristalsism of the gastrointestinal tract that may be possible at both local and central levels. From the reviewed literature on diphenoxilate chlorhydrate, we chose the high-performance liquid chromatography since this was the method suggested in the drug registry for the study of stability in the formulation of this active principle. The method for the determination of atropine sulphate is included in USP 23 and the selection criterium was one of the less complex criteria for the quantification of this substance. Taking the set regulations that assure the compliance with the good manufacturing practices into consideration, the present paper is aimed at the prospective validation of methods for the quantification of Reasec´s component active principles; hence, specificity, accuracy, precision, linearity and range studies were performed. The requirements set for the analytical methods included in the category I were complied with because they are used in the quantification of the active principles of the formulation. The achieved results showed that both analytical methods are reliable since they allow the quantification of the two active principles and fulfill the requirements established for the evaluation parameters within the category which each of them belongs to.
Palabras clave : DIPHENOXILATE [analysis]; ANTIDIARRHEALS [therapeutic use]; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, GAS; CHEMISTRY PHARMACEUTICAL; TECHNOLOGY, PHARMACEUTICAL.