Structural studies of impurities of risperidone by hyphenated techniques

J Pharm Biomed Anal. 2006 Feb 24;40(3):598-604. doi: 10.1016/j.jpba.2005.10.034. Epub 2005 Nov 28.

Abstract

During the impurity profile of risperidone (RSP), a more polar impurity (RSP-1) and a more non-polar impurity (RSP-2) were detected in LC-MS with respect to risperidone. These impurities were isolated, enriched and were subjected to mass and NMR spectral studies. Based on the spectral data, RSP-1 and RSP-2 were characterized as risperidone N-oxide and 9-methylene risperidone, respectively. The formation of these impurities is rationalized. The structures of both the impurities were unambiguously confirmed by single crystal XRD Studies.

MeSH terms

  • Antipsychotic Agents / analysis*
  • Antipsychotic Agents / chemistry
  • Chromatography, High Pressure Liquid
  • Crystallography, X-Ray
  • Drug Contamination
  • Indicators and Reagents
  • Magnetic Resonance Spectroscopy
  • Mass Spectrometry
  • Risperidone / analogs & derivatives*
  • Risperidone / analysis*
  • Risperidone / chemistry

Substances

  • Antipsychotic Agents
  • Indicators and Reagents
  • Risperidone