NDLI: Validação de metodologia analítica por cromatografia líquida de alta eficiência para doseamento de cápsulas de fluoxetina

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Validação de metodologia analítica por cromatografia líquida de alta eficiência para doseamento de cápsulas de fluoxetina

Content Provider	Semantic Scholar
Author	Prado, Johannes N. Do Pissatto, Stela Morais, Elayne C. De Foppa, Talize Murakami, Fábio Seigi Silva, Marcos Antônio Segatto
Copyright Year	2006
Abstract	RESUMO. Um método analítico utilizando cromatografia líquida de alta eficiência (CLAE) foi validado para quantificar fluoxetina em cápsulas. O ensaio utilizou uma coluna de RP-C18 com detector ultravioleta a 226 nm e fase móvel constituída de acetonitrila e tampão fosfato 0,05M pH 3,0 (1:1v/v), com fluxo 1,0 mL/min e isocrático. Os parâmetros utilizados no processo de validação foram: linearidade, intervalo, precisão, especificidade, exatidão e robustez. Todos os resultados se mostraram satisfatórios, o método demonstrou-se adequado para a quantificação de fluoxetina em cápsulas, considerando os parâmetros especificados pela ANVISA-Brasil Resolução 899/2003 e ICH. SUMMARY. “Validation of a High Performance Liquid Chromatographic Method for the Determination of Fluoxetine Capsules”. An analytical method using a sensitive high pressure liquid chromatographic (HPLC) technique was validated to quantify fluoxetine in capsule dosage form. The analysis was carried out using a RP-C18 column with ultraviolet detection at 226 nm. The mobile phase was acetonitrile and phosphate buffer 0.05M pH 3.0 (1:1v/v) at 1.0 mL/min. The parameters used in the validation process were: linearity, interval, accuracy, specificity, precision and robustness. Results were satisfactory and the method proved to be adequate, considering ANVISA-Brasil Resolution 899/2003 and ICH.
File Format	PDF HTM / HTML
Alternate Webpage(s)	http://www.latamjpharm.org/trabajos/25/3/LAJOP_25_3_3_1_PQ529DAG5Z.pdf
Language	English
Access Restriction	Open
Content Type	Text
Resource Type	Article

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