Validación del método analítico por cromatografía líquida de alta eficiencia (HPLC) para la cuantificación de clorhidrato de amiodarona tabletas 200 mg
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El presente trabajo tiene como objetivo validar un método analítico según ANVISA para la determinación de clorhidrato de amiodarona en comprimidos utilizando la técnica de cromatografía liquida de alta eficiencia (HPLC), el método es isocrático de fase reversa y una fase móvil compuesta por buffer fosfato monobásico de sodio que fue llevado con ácido fosfórico a pH de 2,19 y acetonitrilo (30:70) más 0,5mL de trietilamina con un flujo constante de 1,5 ml/min, un volumen de inyección de 5µL a una temperatura de 30 0C y una longitud de onda de 240 nm. Para este análisis se utilizó una columna Symetric C8 3,5 um x 4, x 150 mm logrando un tiempo de retención de 2,1 minutos. La especificidad se demostró mediante un estudio de degradación forzada de clorhidrato de amiodarona, en HCl 0.1M, NaOH 0.1M y H2O2 al 3% en diversas condiciones de estrés a concentraciones de 50 ppm, 100 ppm y 1000 ppm respectivamente.
ABSTRACT The present work aims to validate an analytical method according to ANVISA for the determination of amiodarone hydrochloride in tablets using the high-efficiency liquid chromatography (HPLC) technique, the method is iocratic with a reversed phase and a mobile phase composed of monobasic phosphate buffer. sodium that was brought with phosphoric acid at pH 2.19 and acetonitrile (30:70) plus 0.5 ml of triethylamine with a constant flow of 1.5 ml / min, an injection volume of 5 µL at a temperature of 30 0C and a wavelength of 240 nm. For this analysis, a Symetric C8 3.5 um x 4.1 x 150 mm column was used, achieving a retention time of 2.1 minutes. Specificity was demonstrated by a forced degradation study of amiodarone hydrochloride, in 0.1M HCl, 0.1M NaOH and 3% H2O2 under various stress conditions at concentrations of 50 ppm, 100 ppm and 1000 ppm respectively.
ABSTRACT The present work aims to validate an analytical method according to ANVISA for the determination of amiodarone hydrochloride in tablets using the high-efficiency liquid chromatography (HPLC) technique, the method is iocratic with a reversed phase and a mobile phase composed of monobasic phosphate buffer. sodium that was brought with phosphoric acid at pH 2.19 and acetonitrile (30:70) plus 0.5 ml of triethylamine with a constant flow of 1.5 ml / min, an injection volume of 5 µL at a temperature of 30 0C and a wavelength of 240 nm. For this analysis, a Symetric C8 3.5 um x 4.1 x 150 mm column was used, achieving a retention time of 2.1 minutes. Specificity was demonstrated by a forced degradation study of amiodarone hydrochloride, in 0.1M HCl, 0.1M NaOH and 3% H2O2 under various stress conditions at concentrations of 50 ppm, 100 ppm and 1000 ppm respectively.
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Keywords
Validación, clorhidrato de amiodarona, método analítico.