Desarrollo y Validación de un método analítico verde HPLC para la determinación de mebendazol 20 mg/ mL en suspensión
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Date
2024
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Universidad Nacional de Trujillo
Abstract
El objetivo de la presente investigación fue desarrollar y validar el método analítico verde HPLC, para la cuantificación de mebendazol 20mg/mL en suspensión. El desarrollo analítico se hizo en un cromatógrafo Agilent 1100 y para la separación de Mebendazol se empleó la columna cromatográfica Kromasil® C18. El método cromatográfico fue isocrático, con una fase móvil compuesta por etanol y una solución amortiguadora de pH 3,0 en proporción 70:30, lo que lo calificó como un método verde debido al uso de etanol como solvente. La velocidad de flujo fue de 0,8 mL/min y la longitud de onda de detección fue de 295 nm; con un tiempo de retención de 3,6 minutos. El método mostró una linealidad con un coeficiente de determinación (R²) superior a 0,99. La exactitud fue conforme dentro del rango de 98 – 102 %, con una desviación estándar relativa (RSD) inferior al 2%. El RSD fue menor del 2% tanto en la repetibilidad como en la precisión intermedia. Además, el método demostró ser robusto, ya que variaciones pequeñas en el pH no afectaron significativamente la eficiencia cromatográfica, manteniendo un RSD inferior al 2%. En conclusión, el método analítico verde desarrollado por HPLC cumplió con todos los parámetros de desempeño requeridos, siendo adecuado y confiable para la cuantificación de mebendazol 20mg/mL en suspensión.
ABSTRACT The objective of the present investigation was to develop and validate the green HPLC analytical method for the quantification of Mebendazole 20mg/mL in suspension. The analytical development was done in an Agilent 1100 chromatograph and the Kromasil® C18 chromatographic column was used for the separation of Mebendazole. The chromatographic method was isocratic, with a mobile phase composed of ethanol and a buffer solution of pH 3.0 in a 70:30 ratio, which qualifies it as a green method due to the use of ethanol as solvent. The flow rate was 0.8 mL/min and the detection wavelength was 295 nm; with a retention time of 3.6 minutes. The method showed linearity with a coefficient of determination (R²) greater than 0.99. Accuracy was compliant within the range of 98 - 102 %, with a relative standard deviation (RSD) of less than 2%. The RSD was less than 2% for both repeatability and intermediate precision. In addition, the method proved to be robust, as small variations in pH will not significantly affect chromatographic efficiency, while maintaining an RSD of less than 2%. In conclusion, the developed green HPLC analytical method meets all the required performance parameters, being suitable and reliable for the quantification of Mebendazole 20mg/mL in suspension
ABSTRACT The objective of the present investigation was to develop and validate the green HPLC analytical method for the quantification of Mebendazole 20mg/mL in suspension. The analytical development was done in an Agilent 1100 chromatograph and the Kromasil® C18 chromatographic column was used for the separation of Mebendazole. The chromatographic method was isocratic, with a mobile phase composed of ethanol and a buffer solution of pH 3.0 in a 70:30 ratio, which qualifies it as a green method due to the use of ethanol as solvent. The flow rate was 0.8 mL/min and the detection wavelength was 295 nm; with a retention time of 3.6 minutes. The method showed linearity with a coefficient of determination (R²) greater than 0.99. Accuracy was compliant within the range of 98 - 102 %, with a relative standard deviation (RSD) of less than 2%. The RSD was less than 2% for both repeatability and intermediate precision. In addition, the method proved to be robust, as small variations in pH will not significantly affect chromatographic efficiency, while maintaining an RSD of less than 2%. In conclusion, the developed green HPLC analytical method meets all the required performance parameters, being suitable and reliable for the quantification of Mebendazole 20mg/mL in suspension
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Antiparasitarios. Estudios de validación. Métodos de análisis.