Stability indicating LC method for the determination of pipamperone

J Pharm Biomed Anal. 2005 Oct 4;39(5):914-9. doi: 10.1016/j.jpba.2005.05.031. Epub 2005 Jul 22.

Abstract

A high performance liquid chromatographic method for the determination of pipamperone in the presence of one related impurity and its degradation products is described. The method is based on the use of an amide functionalized bonded phase column (LC-ABZ+ Plus) and a mobile phase of acetonitrile-tetrahydrofuran-sodium phosphate monobasic (0.05 M, pH 6.5) (16:11:73, v/v/v). All peaks are eluted in <8 min. The method was demonstrated to be precise, accurate and specific. Degradation study showed that the drug is stable in acidic medium while it degrades under basic and oxidative conditions. The results indicated that the proposed method could be used in a stability assay.

MeSH terms

  • Antipsychotic Agents / analysis*
  • Butyrophenones / analysis*
  • Calibration
  • Chromatography, Liquid
  • Drug Stability
  • Hydrogen-Ion Concentration
  • Indicators and Reagents
  • Reproducibility of Results
  • Sodium Hydroxide / chemistry
  • Solutions
  • Spectrophotometry, Ultraviolet

Substances

  • Antipsychotic Agents
  • Butyrophenones
  • Indicators and Reagents
  • Solutions
  • pipamperone
  • Sodium Hydroxide