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Validación del método analítico para la determinación de glimepirida en plasma humano por HPLC/UV con adición de estándar empleando glibenclamida como estándar interno

Ars pharmaceutica, ISSN 0004-2927, Vol. 46, Nº. 4, 2005, pags. 411-427
Source: OAI

ABSTRACT Se desarrolló un método para la detección y cuantificación de Glimepirida en plasma humano, con elución isocrática por cromatografía líquida de fase reversa, con detección ultravioleta a 231 nm, empleando el método de adición de estándar. Se utilizó Glibenclamida como estándar interno. Este método involucra una extracción líquida de los principios activos (Glimepirida y Glibenclamida) usando una mezcla de diclorometano:dietiléter (30:70 v/v). La separación se realizó en una columna C 18 en fase reversa y la fase móvil consistió de una mezcla de acetonitrilo:agua (45:55 v/v) ajustado a pH 3.3±0.1 con ácido acético glacial. El método se validó en el rango de concentraciones de 0.001 a 1.0 µg/mL con adición de estándar de Glimepirida de 0.25 µg/mL. La curva de calibración fue lineal en el rango de concentraciones establecido. Se evaluó la reproducibilidad, estabilidad y porcentaje de recuperación del método. El método para la determinación de Glimepirida en plasma humano por HPLC/UV fue preciso y exacto, con un límite de cuantificación de 0.2025 µg/mL. Este método fue suficientemente sensible para su aplicación en estudios farmacocinéticos de glimepirida.

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