Development of Spectrophotometric Method to Assay Phenylephrine Hydrochloride in Pure and in its Pharmaceutical Forms Using Diazotized Sulphanilic Acid

• H. Ahmed, Hanan ^[1] ; Mohammed, Salim ^[1]
  1. [1] University of Mosul

     University of Mosul

     Irak

     
• Localización: Revista Politécnica, ISSN-e 2477-8990, Vol. 53, Nº. 1, 2024 (Ejemplar dedicado a: Revista Politécnica), págs. 39-46
• Idioma: inglés
• DOI: 10.33333/rp.vol53n1.04
• Títulos paralelos:
  • Desarrollo de un Método Espectrofotométrico para Analizar el Clorhidrato de Fenilefrina en Forma Pura y Farmacéutica Utilizando Ácido Sulfanílico Diazotizado
• Enlaces
  • Texto completo
• Resumen
  • español

    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.

     

  • English

    This work described a simple and sensitive spectrophotometric procedure for estimating phenylephrine hydrochloride in pure and in its pharmaceutical using diazotized sulphanilic acid as a coupling agent in alkaline medium of sodium carbonate solution. The resulting yellow azo-dye displayed an absorption maximum at 441 nm. The calibration graph was linear and compatible to Beer's law over the concentration range 0.2-20 µg/mL with coefficient estimated (r2=0.9996). The values of molar absorptivity and the sensitivity of Sandell's index were calculated and equal to 8.51×103 l/mol.cm and0.0239 µg/cm2, respectively. The values of detection limit (LOD), quantification limit (LOQ) and the range of relative error percentage were estimated and found to be 0.0050, 0.0166 µg/mL and -0.374% to -0.147%, respectively. The precision (represented by RSD) was also calculated and found to be in the range ±0.037 to ±0.28. The suggested procedure was useful successfully to the assay of phenylephrine hydrochloride in injection, drops and syrups. No interferences were observed from common additives found in pharmaceutical preparations. The yellow color of the product was highly stable and did not show a significant change in absorbance up to 60 min.

     

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