Abstract

GARCIA PENA, Caridad Margarita et al. Analytical method for quantification and dissolution essay of 3 mg tablets of Risperidone. Rev Cubana Farm [online]. 2009, vol.43, n.4, pp. 31-44. ISSN 1561-2988.

A high-performance liquid chromatography analytical method was developed for quantification and in dissolution assay of 3 mg Risperidone tablets. Method was based in active principle separation through a Lichrosorb RP-18 (250 x 4 mm) chromatographic column with UV detection to 278 nm using a mobile phase composed of 0.05 potassium phosphate buffer:acetonitrile, of 45:55 ratio. Method for active principle quantification was validated through linearity, specificity, precision and accuracy of system. Whereas in dissolution assay validation the linearity, precision, specificity and filtrate influence was assessed. Both methods were simple, fast and economic as well as specific, linear, precise and exact within the study concentrations rank. The alternative analytical method developed for 3 mg Risperidona tablets quantification and dissolution was statistically compared to method proposed by USA Pharmacopeia demonstrating that there were not significant differences among the results achieved by each method.

Keywords : Risperidone; dissolution; quantification; alidation; high-performance liquid chromatography.

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