Development and Validation of a Sensitive and Fast Solid-phase Spectrophotometric Procedure for Phenol Determination in Pharmaceuticals

Abstract

A very sensitive, simple, and fast solid-phase spectrophotometric procedure for the determination of phenol using the p-nitrobenzenediazonium reagent (DAR reagent) was developed. This procedure is based on the simultaneous concentration of the orange product on a Dowex 1-X2 anion exchanger within 15 min, and a direct absorbance measurement of the sorbed species at both 530 nm (the absorption maximum of the phenol-DAR in the resin phase) and 700 nm (the range where only the resin absorbs light). Quality control and evaluation of the analytical parameters was carried out using a comprehensive prevalidation strategy. The linearity of the method was confirmed within an analyte working range from 0.01 to 0.10 μmol (0.2 to 2.0 nmol mL -1 ). The precision ranged from ±1.17 to ±9.61%; the accuracy ranged from -17.50 to +17.81%. The evaluated limiting values were LD = 0.0013 μmol and LQ = 0.0082 μmol. The DAR-SPS method was successfully applied to the determination of phenol in a pharmaceutical sample of salicylic acid (98.0 -100.0%) and vaccines (98.0 -103.4%).

Validación De Un Método Analítico Para La Determinación De Fósforo Por Espectrofotometría Ultravioleta-Visible

“…Sin embargo, la gran mayoría de los trabajos recientes de validación de métodos analíticos tienen una gran aplicación en la investigación de productos farmacéuticos. Entre estos métodos analíticos validados se encuentra la determinación y/o cuantificación de sertralina (Walash et al, 2011), candesartan (Pradhan et al, 2011), determinación de fenol en productos farmacéuticos (Vukovic et al, 2012), desloratadina (Derayea, 2014), cromoglicato de sodio y clorhidrato de oximetazolina (Abdel-Aziz et al, 2014) entre otros.…”