Calibration and validation of a MCC/IMS prototype for exhaled propofol online measurement

J Pharm Biomed Anal. 2017 Oct 25:145:293-297. doi: 10.1016/j.jpba.2017.06.052. Epub 2017 Jul 1.

Abstract

Propofol is a commonly used intravenous general anesthetic. Multi-capillary column (MCC) coupled Ion-mobility spectrometry (IMS) can be used to quantify exhaled propofol, and thus estimate plasma drug concentration. Here, we present results of the calibration and analytical validation of a MCC/IMS pre-market prototype for propofol quantification in exhaled air. Calibration with a reference gas generator yielded an R2≥0.99 with a linear array for the calibration curve from 0 to 20 ppbv. The limit of quantification was 0.3 ppbv and the limit of detection was 0.1 ppbv. The device is able to distinguish concentration differences >0.5 ppbv for the concentration range between 2 and 4 ppbv and >0.9 ppbv for the range between 28 and 30 ppbv. The imprecision at 20 ppbv is 11.3% whereas it is 3.5% at a concentration of 40 ppbv. The carry-over duration is 3min. The MCC/IMS we tested provided online quantification of gaseous propofol over the clinically relevant range at measurement frequencies of one measurement each minute.

Keywords: Anesthesia; Breath analysis; Calibration; Drug monitoring; Multi-capillary column coupled ion-mobility spectrometer; Propofol.

Publication types

  • Validation Study

MeSH terms

  • Anesthetics, Intravenous
  • Breath Tests
  • Calibration
  • Exhalation
  • Online Systems
  • Propofol / analysis*
  • Spectrum Analysis

Substances

  • Anesthetics, Intravenous
  • Propofol