Validación de una metodología por cromatografía líquida de alta resolución para la valoración de cloruro de benzalconio en Gentamicina 0,3% solución oftálmica
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El presente informe de investigación tuvo por objetivo demostrar la validación de una metodología para la valoración del preservante Cloruro de Benzalconio en una solución oftálmica como forma farmacéutica, cuyos resultados obtenidos son confiables, consistentes y reproducibles en las condiciones ya establecidas; considerando que la validación es un requisito de bastante importancia para cumplir con las buenas prácticas de laboratorio. La metodología se basó en la separación y cuantificación del analito de interés por cromatografía líquida de alta resolución en fase reversa Para lo cual se realizaron ciertos parámetros de desempeño, evaluándose: la especificidad, linealidad, exactitud, precisión, robustez y rango. Definidos los parámetros de desempeño recomendadas por según la normativa vigente de la Farmacopea de los Estados Unidos (USP), se realizaron los análisis pertinentes para la evaluación de los mismos; lo cual demostró que la metodología es especifica ya que se obtuvo por resultado la ausencia de interferencia por parte de los excipientes o posibles productos de degradación en el análisis del analito de interés, es lineal ya que se evidenció un coeficiente de correlación de r = 0,9998, es precisa por presentar valores por debajo de la especificación de desviación estándar relativa (DRS<2%), es exacta por encontrarse un recuperación promedia de 99,88% dentro de la especificación correspondiente, es robusto por cumplir con los criterios de aceptación de Coeficiente de variación dentro del 2% de la variación aceptable y dentro del rango establecido. Por lo cual se concluye que la metodología por cromatografía líquida de alta resolución demuestra ser específica, lineal, exacta, precisa y robusta para la valoración de Cloruro de Benzalconio en Gentamicina 0,3% Solución Oftálmica.
ABSTRACT The objective of this research report was to demonstrate the validation of a methodology for the evaluation of the preservative Benzalkonium Chloride in an ophthalmic solution as a pharmaceutical form, whose results obtained are reliable, consistent and reproducible under the conditions already established; considering that validation is a requirement of considerable importance to comply with good laboratory practices. The methodology was based on the separation and quantification of the analyte of interest by high-resolution liquid chromatography in reversed phase. For which certain performance parameters were performed, evaluating: specificity, linearity, accuracy, precision, robustness and range. Once the performance parameters recommended by according to the current regulations of the United States Pharmacopeia (USP) were defined, the pertinent analyzes were carried out for their evaluation; which showed that the methodology is specific since the absence of interference by excipients or possible degradation products in the analysis of the analyte of interest was obtained as a result, it is linear since a correlation coefficient of r = 0.9998 was evidenced, it is accurate because it presents values below the relative standard deviation specification (DRS <2%), it is accurate because it finds an average recovery of 99.88% within the corresponding specification, it is robust because it meets the criteria of acceptance of Coefficient of variation within 2% of the acceptable variation and within the established range. Therefore, it is concluded that the high-resolution liquid chromatography methodology proves to be specific, linear, exact, precise and robust for the evaluation of Benzalkonium Chloride in Gentamicin 0.3% Ophthalmic Solution.
ABSTRACT The objective of this research report was to demonstrate the validation of a methodology for the evaluation of the preservative Benzalkonium Chloride in an ophthalmic solution as a pharmaceutical form, whose results obtained are reliable, consistent and reproducible under the conditions already established; considering that validation is a requirement of considerable importance to comply with good laboratory practices. The methodology was based on the separation and quantification of the analyte of interest by high-resolution liquid chromatography in reversed phase. For which certain performance parameters were performed, evaluating: specificity, linearity, accuracy, precision, robustness and range. Once the performance parameters recommended by according to the current regulations of the United States Pharmacopeia (USP) were defined, the pertinent analyzes were carried out for their evaluation; which showed that the methodology is specific since the absence of interference by excipients or possible degradation products in the analysis of the analyte of interest was obtained as a result, it is linear since a correlation coefficient of r = 0.9998 was evidenced, it is accurate because it presents values below the relative standard deviation specification (DRS <2%), it is accurate because it finds an average recovery of 99.88% within the corresponding specification, it is robust because it meets the criteria of acceptance of Coefficient of variation within 2% of the acceptable variation and within the established range. Therefore, it is concluded that the high-resolution liquid chromatography methodology proves to be specific, linear, exact, precise and robust for the evaluation of Benzalkonium Chloride in Gentamicin 0.3% Ophthalmic Solution.
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Keywords
Cloruro de Benzalconio, Cromatografía