Stability behaviour of antiretroviral drugs and their combinations. 5: Characterization of novel degradation products of abacavir sulfate by mass and nuclear magnetic resonance spectrometry

J Pharm Biomed Anal. 2017 Feb 5:134:372-384. doi: 10.1016/j.jpba.2016.10.019. Epub 2016 Nov 5.

Abstract

In the present study, degradation behaviour of abacavir sulfate was evaluated in solution and solid stress conditions. Solution state studies resulted in formation of eleven degradation products; of which two were also formed on solid stress. The same were separated by high performance liquid chromatography. They were characterized using liquid chromatography-high resolution mass spectrometry, liquid chromatography-multistage mass spectrometry and hydrogen/deuterium exchange mass spectrometry data. Additionally, seven degradation products were isolated and subjected to 1D and 2D nuclear magnetic resonance studies for their structural confirmation.

Keywords: Abacavir sulfate; Degradation products; Mass spectrometry; NMR spectrometry; Stress testing.

MeSH terms

  • Anti-Retroviral Agents / analysis*
  • Anti-Retroviral Agents / chemistry
  • Chromatography, High Pressure Liquid / methods
  • Dideoxynucleosides / analysis*
  • Dideoxynucleosides / chemistry
  • Drug Combinations
  • Drug Stability
  • Magnetic Resonance Spectroscopy / methods*
  • Mass Spectrometry / methods

Substances

  • Anti-Retroviral Agents
  • Dideoxynucleosides
  • Drug Combinations
  • abacavir