A porous graphitized carbon column HPLC method for the quantification of paracetamol, pseudoephedrine, and chlorpheniramine in a pharmaceutical formulation

J AOAC Int. 2010 Jul-Aug;93(4):1093-101.

Abstract

A simple, rapid, and stability-indicating HPLC method has been developed, fully validated, and applied to the quantification of paracetamol, pseudoephedrine hydrochloride, and chlorpheniramine maleate in a pharmaceutical formulation, using hydrochlorothiazide as an internal standard. Chromatographic separation was achieved isocratically on an RP porous graphitized carbon analytical column (125 x 2.1 mm id, particle size 5 microm) using 5.0 mM ammonium acetate-acetonitrile (35 + 65, v/v) mobile phase at a flow rate of 0.50 mL/min. UV spectrophotometric detection at 220 nm was used. The method had linear calibration curves over the range of 30-70 microg/mL for paracetamol, 1.8-4.2 microg/mL for pseudoephedrine hydrochloride, and 120-280 ng/mL for chlorpheniramine maleate. The intraday and interday RSD values were less than 3.2% for all compounds, while the relative error was less than 2.9%. Accelerated stability studies performed under various stress conditions proved the selectivity of the method. The developed method was applied successfully to QC and content uniformity tests of commercial tablets.

MeSH terms

  • Acetaminophen / analysis*
  • Calibration
  • Chlorpheniramine / analysis*
  • Chromatography, High Pressure Liquid / methods*
  • Drug Combinations
  • Limit of Detection
  • Pseudoephedrine / analysis*
  • Quality Control
  • Tablets

Substances

  • Drug Combinations
  • Tablets
  • Acetaminophen
  • Chlorpheniramine
  • Pseudoephedrine