Validación de método analítico empleado para estudios de permeación intestinal de sistemas transportadores que contienen gemfibrozilo
Fecha
2018
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
El presente estudio tiene como objetivo validar un método analítico para la cuantificación de las concentraciones de gemfibrozilo incorporado a microemulsiones que puedan ser absorbidas por la mucosa intestinal, para lo que se emplearon los parámetros descritos por la United State Pharmacopeia (USP) 39 e International Conference on Harmonization (ICH) (2005). El desarrollo experimental se llevó a cabo en las instalaciones del laboratorio de Análisis de Medicamentos de la Facultad de Ciencias Químicas de la Universidad de Guayaquil. El equipo utilizado para la determinación fue un espectrofotómetro ultravioleta UV / VIS (Shimadzu 1700-UV®). El método desarrollado demostró linealidad con un coeficiente de determinación (R2) de
0,9984 además de precisión, exactitud y robustez para cada uno de los ensayos con valores que presentaron un coeficiente de variación menor al 5%. Los resultados obtenidos fueron favorables, ya que cumplen con los parámetros estipulados por la USP 39 e ICH (2005), lo que indica que el método es eficaz para la finalidad pretendida
The present study aims to validate an analytical method for the quantification of gemfibrozil concentrations incorporated into microemulsions that can be absorbed by the intestinal mucosa and to accomplish that, parameters described by the United State Pharmacopeia (USP) 39 and International Conference on Harmonization (ICH) (2005) were used. The experimental development was carried out in the facilities of the Medicine Analysis Laboratory of the Faculty of Chemical Sciences of the University of Guayaquil. The equipment used for the determination was a UV / VIS ultraviolet spectrophotometer (Shimadzu 1700-UV®). The developed method showed a linearity with a coefficient of determination (R2) of 0.9984, as well as precision, accuracy and robustness for each of the tests with values that showed a coefficient of variation less than 5%. The results obtained were favorable, since they comply with the parameters stipulated by USP 39 and ICH (2005), which indicates that the method is effective for the intended purpose
The present study aims to validate an analytical method for the quantification of gemfibrozil concentrations incorporated into microemulsions that can be absorbed by the intestinal mucosa and to accomplish that, parameters described by the United State Pharmacopeia (USP) 39 and International Conference on Harmonization (ICH) (2005) were used. The experimental development was carried out in the facilities of the Medicine Analysis Laboratory of the Faculty of Chemical Sciences of the University of Guayaquil. The equipment used for the determination was a UV / VIS ultraviolet spectrophotometer (Shimadzu 1700-UV®). The developed method showed a linearity with a coefficient of determination (R2) of 0.9984, as well as precision, accuracy and robustness for each of the tests with values that showed a coefficient of variation less than 5%. The results obtained were favorable, since they comply with the parameters stipulated by USP 39 and ICH (2005), which indicates that the method is effective for the intended purpose
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MICROEMULSIONES, VALIDACIÓN MÉTODO ANALÍTICO, GEMFIBROZILO, ABSORCIÓN INTESTINAL