Determination of combined p-hydroxy benzoic acid preservatives in a liquid pharmaceutical formulation by HPLC

J Pharm Biomed Anal. 2004 Jan 27;34(1):207-13. doi: 10.1016/j.japna.2003.07.006.

Abstract

This paper describes a reversed-phase high performance liquid chromatographic (RP-HPLC) assay method for the determination of combined p-hydroxy benzoic acid (ethylparaben (EP), methylparaben (MP) and propylparaben (PP)) preservatives in a liquid pharmaceutical formulation. The chromatographic separation was achieved with potassium phosphate buffer (pH 7.05)-methanol (47.5:52.5, v/v) as mobile phase, a Spherisorb C(18) column (250 mm x 4.6mm) and UV detection at 254 nm. The analysis time was <8 min. The method was validated with respect to linearity, precision, accuracy, selectivity, specificity and ruggedness. The calibration curves showed good linearity over the concentration range of 2-140 microg/ml. The correlation coefficient were >0.9999 in each case. The relative standard deviation (R.S.D.) values for intra- and inter-day precision studies were <1%. The procedure describe here is simple, selective and is suitable for routine quality control analysis and stability tests.

MeSH terms

  • Chemistry, Pharmaceutical
  • Chromatography, High Pressure Liquid / methods
  • Parabens / analysis*
  • Parabens / chemistry
  • Pharmaceutical Solutions / analysis
  • Pharmaceutical Solutions / chemistry
  • Preservatives, Pharmaceutical / analysis*
  • Preservatives, Pharmaceutical / chemistry

Substances

  • Parabens
  • Pharmaceutical Solutions
  • Preservatives, Pharmaceutical
  • 4-hydroxybenzoic acid