Desarrollo de un Método Espectrofotométrico para Analizar el Clorhidrato de Fenilefrina en Forma Pura y Farmacéutica Utilizando Ácido Sulfanílico Diazotizado
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Hanan H. Ahmed
Salim Mohammed
Resumen
Este trabajo describió un procedimiento espectrofotométrico simple y sensible para estimar el clorhidrato de fenilefrina en estado puro y en sus formas farmacéuticas usando ácido sulfanílico diazotado como agente de acoplamiento en medio alcalino de solución de carbonato de sodio. El colorante azoico amarillo resultante mostró un máximo de absorción a 441 nm. El gráfico de calibración fue lineal y compatible con el mínimo de Beer en el intervalo de concentración de 0.2-20 µg/mL con determinación del coeficiente (r2=0.9996). Los valores de absortividad molar y la sensibilidad del índice de Sandell fueron calculados y fueron de 8.51×103 l/mol.cm y 0 0239 µg/cm2, respectivamente. Los valores del límite de detección (LOD), el límite de cuantificación (LOQ) y el rango del porcentaje de error relativo se estimaron y resultaron ser 0.0050, 0.0166 µg/mL y -0.374 % a -0.147 %, respectivamente. También se calculó la precisión (representada por RSD) y se encontró que estaba en el rango de ±0.037 a ±0.28. El procedimiento sugerido fue útil con éxito para el ensayo de clorhidrato de fenilefrina en inyección, gotas y jarabes. No se observaron interferencias de los aditivos comunes que se encuentran en las preparaciones farmacéuticas. El color amarillo del producto fue muy estable y no mostró cambios significativos en la absorbancia hasta los 60 min.
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