US FDA-validated green GC-MS method for analysis of gabapentin, tramadol and/or amitriptyline mixtures in biological fluids

Bioanalysis. 2020 Nov;12(21):1521-1533. doi: 10.4155/bio-2020-0217. Epub 2020 Oct 29.

Abstract

Background: Mixtures of gabapentin, tramadol and/or amitriptyline are usually recommended for treatment of neuropathic pain. Materials & methods/results: A novel GC-MS/MS method was developed to assess the studied mixture whether in pure forms or human biological fluids (plasma/urine). The chromatographic detection was performed using MS detector applying the selected ion-monitoring mode. An (Agilent, CA, USA) GC-MS with triple axis single quadrupole detector unit was used for the analysis equipped with HP-5MS (5% phenyl methyl siloxane) column. Helium was the carrier gas and positive electron impact ionization mode was applied. Conclusion: The developed method was able to assess the mixture components simultaneously within six minutes. Validation of the method was assured according to US FDA guidelines and Eco-Scale assessment.

Keywords: GC–MS/MS; amitriptyline; gabapentin; selected ion monitoring mode; tramadol.

MeSH terms

  • Amitriptyline / analysis
  • Amitriptyline / pharmacology*
  • Gabapentin / analysis
  • Gabapentin / pharmacology*
  • Gas Chromatography-Mass Spectrometry / methods*
  • Humans
  • Tramadol / analysis
  • Tramadol / pharmacology*
  • United States
  • United States Food and Drug Administration

Substances

  • Amitriptyline
  • Tramadol
  • Gabapentin