A sensitive liquid chromatography method for analysis of propofol in small volumes of neonatal blood.
HPLC-fluorescence
neonates
pharmacokinetics
propofol
small blood sample volume
Journal
Journal of clinical pharmacy and therapeutics
ISSN: 1365-2710
Titre abrégé: J Clin Pharm Ther
Pays: England
ID NLM: 8704308
Informations de publication
Date de publication:
Feb 2020
Feb 2020
Historique:
received:
27
02
2019
revised:
10
07
2019
accepted:
08
08
2019
pubmed:
5
10
2019
medline:
8
10
2020
entrez:
5
10
2019
Statut:
ppublish
Résumé
Sampling volumes of blood from neonates is necessarily limited. However, most of the published propofol analysis assays require a relatively large blood sample volume (typically ≥0.5 mL). Therefore, the aim of the present study was to develop and validate a sensitive method requiring a smaller sample volume (0.2 mL) to fulfill clinically relevant research requirements. Following simple protein precipitation and centrifugation, the supernatant was injected into the HPLC-fluorescence system and separated with a reverse phase column. Propofol and the internal standard (thymol) were detected and quantified using fluorescence at excitation and emission wavelengths of 270 nm and 310 nm, respectively. The method was validated with reference to the Food and Drug Administration (FDA) guidance for industry. Accuracy (CV, %) and precision (RSD, %) were evaluated at three quality control concentration levels (0.05, 0.5 and 5 µg/mL). Calibration curves were linear in the range of 0.005-20 µg/mL. Intra- and interday accuracy (-4.4%-13.6%) and precision (0.2%-5.8%) for propofol were below 15%. The calculated LOD (limit of detection) and LLOQ (lower limit of quantification) were 0.0021 µg/mL and 0.0069 µg/mL, respectively. Propofol samples were stable for 4 months at -20°C after the sample preparation. This method was applied for analyzing blood samples from 41 neonates that received propofol, as part of a dose-finding study. The measured median (range) concentration was 0.14 (0.03-1.11) µg/mL, which was in the range of the calibration curve. The calculated median (range) propofol half-life of the gamma elimination phase was 10.4 (4.7-26.7) hours. A minimal volume (0.2 mL) of blood from neonates is required for the determination of propofol with this method. The method can be used to support the quantification of propofol drug concentrations for pharmacokinetic studies in the neonatal population.
Substances chimiques
Anesthetics, Intravenous
0
Propofol
YI7VU623SF
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
128-133Subventions
Organisme : China Scholarship Council (CSC)
ID : 201507040034
Organisme : Agentschap voor innovatie door wetenschap en technologie (IWT), Flanders, Belgium
ID : 111193
Informations de copyright
© 2019 John Wiley & Sons Ltd.
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