Validación de un método analítico ecoamigable para la cuantificación de amlodipino en comprimidos de 5 mg por espectrofotometría UV/Vis
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Date
2024
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Universidad Nacional de Trujillo
Abstract
El objetivo del presente informe fue validar un método analítico ecoamigable por espectrofotometría UV/Vis para la cuantificación de amlodipino en comprimidos de 5 mg. Se evaluaron los parámetros de desempeño analítico: especificidad, linealidad, precisión y exactitud, utilizando como diluyente la mezcla 50:50 de etanol absoluto y solución buffer fosfato 3 mM pH 2,5 y 212 nm como longitud de onda. El ensayo de especificidad demostró que los excipientes y el diluyente no interfirieron en las lecturas, en la prueba de linealidad se obtuvo un coeficiente de correlación (r) de 0,9995 y un coeficiente de determinación (r2) de 0,9989, en la prueba de precisión los valores del coeficiente de variación de repetibilidad del sistema, repetibilidad del método y precisión intermedia fueron de 0,31%, 0,32% y 0,42%, respectivamente (valor de especificación < 2) y en la prueba de exactitud se obtuvo un porcentaje de recuperación de 100,61 % (valor de especificación: 98% - 102%). Por lo tanto, se concluye que el método analítico es específico, lineal, preciso, exacto y aplicable para la cuantificación de amlodipino en comprimidos, constituyendo una buena alternativa para el análisis de rutina en la industria farmacéutica, reemplazando el uso de solventes orgánicos.
ABSTRACT This report aimed to validate an eco-friendly analytical method by UV/Vis spectrophotometry for the quantification of amlodipine in 5 mg tablets. The analytical performance parameters were evaluated: specificity, linearity, precision, and accuracy. The diluent was a 50:50 mixture of absolute ethanol and a 3 mM phosphate buffer solution with a pH 2,5 , and the wavelength was set at 212 nm. The specificity test demonstrated that neither the excipients nor the diluent interfered with the readings. The linearity test yielded a correlation coefficient (r) of 0,9995 and a determination coefficient (r2) of 0,9989. In the precision test, the system repeatability variation coefficient, method repeatability, and intermediate precision were 0,31%, 0,32%, and 0,42%, respectively (with a specification value < 2) and in the accuracy test a recovery percentage of 100,61% was obtained (value of specification: 98% - 102%). In conclusion, the analytical method is specific, linear, precise, accurate, and suitable for quantifying amlodipine in tablets, constituting a good alternative for routine analysis in the pharmaceutical industry, replacing the use of organic solvents.
ABSTRACT This report aimed to validate an eco-friendly analytical method by UV/Vis spectrophotometry for the quantification of amlodipine in 5 mg tablets. The analytical performance parameters were evaluated: specificity, linearity, precision, and accuracy. The diluent was a 50:50 mixture of absolute ethanol and a 3 mM phosphate buffer solution with a pH 2,5 , and the wavelength was set at 212 nm. The specificity test demonstrated that neither the excipients nor the diluent interfered with the readings. The linearity test yielded a correlation coefficient (r) of 0,9995 and a determination coefficient (r2) of 0,9989. In the precision test, the system repeatability variation coefficient, method repeatability, and intermediate precision were 0,31%, 0,32%, and 0,42%, respectively (with a specification value < 2) and in the accuracy test a recovery percentage of 100,61% was obtained (value of specification: 98% - 102%). In conclusion, the analytical method is specific, linear, precise, accurate, and suitable for quantifying amlodipine in tablets, constituting a good alternative for routine analysis in the pharmaceutical industry, replacing the use of organic solvents.
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Keywords
Ecoamigable, espectrofotometría UV/Vis, cuantificación, amlodipino, comprimidos.