Abstract
A novel gas chromatography (GC) method for quantitation of volatile organic compounds (VOCs) in 18F- and 11C-radiopharmaceuticals listed in the European Pharmacopoeia (Ph. Eur.) was proposed. Optimized chromatographic parameters were used for separation of ethanol, acetone, acetonitrile, tetrahydrofuran (THF), dibromomethane (DBM), 2-dimethylaminoethanol (deanol), N,N-dimethylformamide (DMF) and dimethyl sulfoxide (DMSO) which could be detected in radioactive drug samples. The calculated peak resolutions (RS) were higher than 2.0 at ethanol concentration of up to 11 m/m%. Reproducible results could be obtained using base deactivated fused silica wool as packing material of inlet liner. Validation parameters showed excellent linearity (r2 ≥0.9998) in the range from 10 to at least 120% of concentration limit of solvents. The accuracy was determined as recovery of concentrations which ranged from 99.3% to 103.8%. Additionally, the relative standard deviation (RSD) of each solvent for inter-day and intra-day precision were in the range of 0.5–4.2% and 0.4–4.4%, respectively. The limit of quantitation (LOQ) for ethanol, acetone, acetonitrile, THF, DBM, deanol, DMF and DMSO was 0.48, 0.42, 0.43, 0.46, 4.35, 0.73, 0.68 and 0.50 mg/L, respectively. The developed procedure was successively applied for quantitation of ethanol, acetone, acetonitrile and deanol in radioactive drug samples of [11C]methionine, [11C]choline, 2-deoxy-2-[18F]fluoro-D-glucose ([18F]FDG) and O-(2-[18F]fluoroethyl)-L-tyrosine ([18F]FET). The proposed GC method applying flame ionization detection (FID) could be adapted in routine quality control of most frequently used positron emission tomography (PET) radiopharmaceuticals to perform the determination of residual solvents with analysis time of 12 min
Highlights
Positron emission tomography is a minimally invasive functional imaging method in nuclear medicine
The goal of this work is to develop a single gas chromatography (GC)-flame ionization detection (FID) method for quantitation of residual solvents which could be detected in 18F- and 11C-radiopharmaceuticals listed in the European Pharmacopoeia
According to the European Pharmacopoeia monographs and scientific papers most frequently used 18F- and 11C-labeled radio pharmaceuticals might contain residual solvents which are listed in Table 1 [2,22,23,24,25,26,27,28,29]
Summary
Positron emission tomography is a minimally invasive functional imaging method in nuclear medicine. Computed tomography (CT) and magnetic resonance imaging (MRI) were successfully combined with PET and the emerged multimodality systems revolutionized the clin ical imaging and disease characterization in the past two decades. PET/CT and PET/MRI hybrid techniques have been widely used in oncology, cardiology, neurology and could be applied in drug development as well [1]. Pathological and physiological processes can be examined in vivo by PET using biologically active molecules labeled with positron emitting isotopes. Radiotracers are usually formulated as sterile injections for intravenous administration. The European Pharmacopoeia comprises quality standards of several radio pharmaceuticals predominantly with oncological indications [2]. [18F]FDG could be applied for visualization of tumors having
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