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Revista Cubana de Farmacia
versão On-line ISSN 1561-2988
Resumo
SUAREZ PEREZ, Yania; IZQUIERDO CASTRO, Adalberto e MILIAN SANCHEZ, Jana María. A chromatographic method validation to quantify tablets Mephenesine of national production. Rev Cubana Farm [online]. 2009, vol.43, n.2, pp. 0-0. ISSN 1561-2988.
Authors made validation of an analytical method by high performance liquid chromatography (HPLC) for quantification of Mephenesine in recently reformulated 500 mg tablets. With regard to its application to quality control, validation included the following parameters: linearity, accuracy, precision, and selectivity. Results were satisfactory within 50-150 % rank. In the case of its use in subsequent studies of chemical stability, the selectivity for stability and sensitivity was assessed. Estimated detection and quantification limits were appropriate, and the method was selective versus the possible degradation products.
Palavras-chave : Mephenesine; stability; high performance liquid chromatography; tablets; quality control.