LC-MS determination of fentanyl in human serum and application to a fentanyl transdermal delivery pharmacokinetic study

Bioanalysis. 2017 Oct;9(20):1551-1560. doi: 10.4155/bio-2017-0174. Epub 2017 Sep 15.

Abstract

Aim: Fentanyl is an opioid agonist used for acute and chronic pain management. In this report, a highly sensitive and simple LC-MS/MS method using Hydrophilic Interaction Chromatography (HILIC) column was validated and used for fentanyl quantification in human serum.

Results: The isocratic mobile phase was composed of acetonitrile: 10 mM ammonium formate buffer (pH = 3.2; 90:10, v/v). The assay was linear over a concentration range of 10-10,000 pg/ml. The accuracy of the validation method ranged from 93.2 to 107%, and the precision was within 6.4%. Fentanyl was stable during short- and long-term storage.

Conclusion: The assay has been successfully applied to serum samples obtained from healthy subjects of a fentanyl transdermal pharmacokinetic study.

Keywords: HILIC; LC-MS/MS; TDS; fentanyl.

MeSH terms

  • Administration, Cutaneous
  • Analgesics, Opioid / blood*
  • Analgesics, Opioid / pharmacokinetics
  • Analgesics, Opioid / standards
  • Chromatography, High Pressure Liquid* / standards
  • Fentanyl / blood*
  • Fentanyl / pharmacokinetics
  • Fentanyl / standards
  • Half-Life
  • Humans
  • Hydrophobic and Hydrophilic Interactions
  • Quality Control
  • Reproducibility of Results
  • Tandem Mass Spectrometry* / standards

Substances

  • Analgesics, Opioid
  • Fentanyl