Development and validation of a sensitive and fast solid-phase spectrophotometric procedure for phenol determination in pharmaceuticals

Anal Sci. 2012;28(4):397-402. doi: 10.2116/analsci.28.397.

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 L(D) = 0.0013 µmol and L(Q) = 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%).

MeSH terms

  • Chemistry, Pharmaceutical / methods*
  • Drug Contamination*
  • Hydrogen-Ion Concentration
  • Indicators and Reagents / chemistry
  • Ion Exchange
  • Nitrobenzenes / chemistry
  • Pharmaceutical Preparations
  • Phenol / analysis
  • Reproducibility of Results
  • Salicylic Acid / analysis*
  • Sensitivity and Specificity
  • Vaccines / analysis*

Substances

  • Indicators and Reagents
  • Nitrobenzenes
  • Pharmaceutical Preparations
  • Vaccines
  • Phenol
  • nitrobenzene
  • Salicylic Acid