Métodos analíticos para evaluar la estabilidad de la rutina y analizar la formación de sus productos de degradación: una revisión
DOI:
https://doi.org/10.33448/rsd-v11i12.34657Palabras clave:
Rutina; Estabilidad fisicoquímica; Productos de degradación; Método indicativo de estabilidad.Resumen
La rutina (RUT) es un flavonoide que se encuentra en una amplia variedad de vegetales. Tiene múltiples propiedades terapéuticas, estando especialmente indicado como venotónico para el tratamiento de la insuficiencia venosa crónica (IVC). Para la obtención de medicamentos compuestos por RUT o asociados a otros fármacos, es necesario evaluar inicialmente la estabilidad del principio activo farmacéutico (PAF), con el fin de garantizar la eficacia y calidad de los productos, así como la seguridad de los consumidores. A pesar de ser un presupuesto para el registro de medicamentos, existe escasez de datos en la literatura con respecto a la estabilidad de la PAF de RUT y sus productos derivados, por lo que este trabajo tuvo como objetivo realizar un análisis crítico de las publicaciones que abordan este tema. En vista de la prospección, fue posible dividir la información en tres grupos: evaluación de la estabilidad resultante del proceso extractivo en derivados vegetales, de sistemas de liberación desarrollados con el fin de sortear limitaciones fisicoquímicas intrínsecas de la molécula y en medios reactivos y condiciones ambientales diseñadas para degradar la molécula. Los resultados mostraron que los estudios de estabilidad son un reto desde el punto de vista técnico y analítico, ya que para la realización de pruebas de degradación forzada y el desarrollo de métodos indicativos de estabilidad (MIEs), a pesar de la existencia de guías, resoluciones y compendios internacionales con los lineamientos para orientar las pruebas, cada molécula tiene una naturaleza química única. Por lo tanto, es fundamental construir un perfil de estabilidad para proponer el control de procesos y el desarrollo de formulaciones que contengan adyuvantes que permitan la formación de productos más estables.
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