VALIDACIÓN DE DOS MÉTODOS ANALÍTICOS APLICABLES AL ACICLOVIR POLVO PARA SUSPENSIÓN ORAL 200 MG/5 ML / VALIDATION OF TWO ANALYTICAL METHODS APPLICABLE TO ACYCLOVIR POWDER FOR ORAL SUSPENSION 200 MG/5 ML

Abstract

El aciclovir polvo para suspension, se emplea en el tratamiento de infecciones por virus herpes simple, en la profilaxis de infecciones por virus herpes simple en pacientes inmunocomprometidos, en pacientes inmunodeprimidos con herpes zoster, especialmente en infecciones cutaneas progresivas o diseminadas, en infecciones por virus herpes simple en neonatos, entre otras. El objetivo del presente trabajo consistio en desarrollar y validar dos metodos analiticos por espectrofotometria y cromatografia liquida de alta resolucion para aplicarlo al control de la calidad y estudio de estabilidad del polvo para suspension; y comparar estadisticamente los resultados obtenidos por ambos metodos. Los metodos analiticos fueron validados mediante el analisis de los parametros: linealidad, exactitud, precision (repetibilidad, precision intermedia) y especificidad. Los resultados obtenidos en las validaciones de ambos metodos fueron adecuados. Ambos metodos analiticos resultaron lineales, exactos, precisos y especificos en el rango de concentraciones estudiadas. Se demostro que no existian diferencias significativas entre ambos metodos analiticos, pudiendose emplear ambos metodos en el control de la calidad del producto terminado. Palabras clave : aciclovir, polvo para suspension, Cromatografia Liquida de Alta Resolucion, Espectrofotometria, Validacion. ------------------------------------------- Acyclovir powder for suspension is used in the treatment of herpes simplex virus infections in the prophylaxis of herpes simplex virus infections in immunocompromised patients, in immunocompromised patients with herpes zoster, especially in progressive or disseminated cutaneous infections, in virus infections Herpes simplex in neonates, among others. The objective of the present work was to develop and validate two analytical methods by spectrophotometry and high performance liquid chromatography to apply it to the quality control and stability study of the powder for suspension; And to statistically compare the results obtained by both methods. The analytical methods were validated by analyzing the parameters: linearity, accuracy, precision (repeatability, intermediate precision) and specificity. The results obtained in the validations of both methods were adequate. Both analytical methods were linear, exact, precise and specific in the range of concentrations studied. It was demonstrated that there were no significant differences between the two analytical methods, both methods being used to control the quality of the finished product. Keywords: acyclovir, powder for suspension, High Resolution Liquid Chromatography, Spectrophotometry, Validation.