Efavirenz related compounds preparation by hydrolysis procedure: setting reference standards for chromatographic purity analysis

J Pharm Biomed Anal. 2007 Jan 4;43(1):298-303. doi: 10.1016/j.jpba.2006.06.010. Epub 2006 Jul 18.

Abstract

A simple procedure for obtaining and purifying two degradation products of efavirenz (amino alcohol and quinoline derivatives) from drug substance hydrolysis is described. These impurities are known to exhibit very different UV absorbance properties from those of the parent compound, making determination using a quantitation factor (QF) inaccurate. The obtained hydrolysis products were characterized by physicochemical methods to assure identity, purity and strength. Quinoline derivative was of high purity degree (100%) and amino alcohol was 98.74% pure. Both were set as reference standards in chromatographic related compounds test for efavirenz drug substance and tablets analyses.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Alkynes
  • Amino Alcohols / analysis
  • Anti-HIV Agents / analysis*
  • Benzoxazines
  • Chemical Phenomena
  • Chemistry, Physical
  • Chromatography, Thin Layer
  • Cyclopropanes
  • Hydrolysis
  • Magnetic Resonance Spectroscopy
  • Oxazines / analysis*
  • Quinolines / analysis
  • Reference Standards
  • Regression Analysis
  • Spectrophotometry, Infrared
  • Tablets

Substances

  • Alkynes
  • Amino Alcohols
  • Anti-HIV Agents
  • Benzoxazines
  • Cyclopropanes
  • Oxazines
  • Quinolines
  • Tablets
  • efavirenz