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Sensitive and selective assay for fentanyl using gas chromatography with mass selective detection
A Szeitz1, K W Riggs, C Harvey-Clark
1Division of Pharmaceutics and Biopharmaceutics, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada.
Journal of Chromatography. B, Biomedical Applications
|January 12, 1996
Summary
A new gas chromatography method accurately quantifies fentanyl in swine serum. This assay is sensitive and selective, proving useful for pharmacokinetic studies of transdermal fentanyl administration in swine.
Area of Science:
- Analytical Chemistry
- Pharmacokinetics
- Veterinary Medicine
Background:
- Accurate quantification of fentanyl in biological matrices is crucial for pharmacokinetic studies.
- Existing methods may lack the required sensitivity or selectivity for specific applications.
- Swine models are frequently used to study drug delivery and pharmacokinetics, including transdermal administration.
Purpose of the Study:
- To develop and validate a modified gas chromatographic assay for the precise quantitation of fentanyl in swine serum.
- To establish a sensitive and selective method suitable for pharmacokinetic investigations.
- To demonstrate the assay's applicability in studying transdermally administered fentanyl in a postoperative swine model.
Main Methods:
- Fentanyl and sufentanil (internal standard) were extracted from swine serum using a single-step liquid-liquid extraction with dichloromethane.
- Quantification was performed using gas chromatography with mass-selective detection (GC-MSD) employing electron-impact ionization (EI) in selected-ion monitoring (SIM) mode.
- Fentanyl and sufentanil were monitored at specific fragment ions (m/z 245 and 289, respectively) to enhance selectivity.
Main Results:
- The assay demonstrated a limit of quantitation (LOQ) of 0.05 ng/ml with a coefficient of variation (C.V.) of 10.8% and a signal-to-noise ratio of 29.
- Standard curves were highly linear (r² = 0.999) over the working range of 0.05-1.5 ng/ml.
- Average recoveries ranged from 69.8% to 91.0%, with intra- and inter-day variances consistently below 12%.
Conclusions:
- The developed GC-MSD assay is sensitive, selective, and accurate for fentanyl quantitation in swine serum.
- The method's performance characteristics support its use in pharmacokinetic studies, particularly for transdermal drug administration.
- This validated assay provides a reliable tool for assessing fentanyl pharmacokinetics in a relevant animal model.