Validation of new gas chromatography-flame ionization detection procedure for quantitation of residual solvents in [18F]FDG
DOI:
https://doi.org/10.15392/bjrs.v7i2A.642Keywords:
Fludeoxyglucose, GC-FID, Method validation, Organic solvents.Abstract
Fludeoxyglucose F 18 ([18F]FDG) is the most used radiopharmaceutical for positron emission tomography, especially on oncology. Organic solvents such as ether, ethanol and acetonitrile might be used in the synthesis of [18F]FDG; however, they might not be completely removed during purification steps. The determination of residual solvents in [18F]FDG is required in the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP) monographs. While the procedure described in the EP is quite general, the one described in the USP requires a long runtime (about 13 minutes). In this work a simple and fast (4-minute) analytical procedure was developed and validated for determination of residual solvents in [18F]FDG. Analyses were carried out by gas chromatography – flame ionization detector (GC-FID). The separation was obtained on a 0.53-mm x 30 m fused-silica column. Validation included the evaluation of various parameters, such as: specificity, linearity and range, limits of detection and quantitation, precision (repeatability and intermediate precision), accuracy, and robustness. Results were found to be within acceptable limits, indicating the developed procedure is suitable for its intended application. Considering the short half-life of fluorine-18 (109.7 minutes), this new method could be a valuable alternative for routine quality control of [18F]FDG.
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AMETAMEY, S.; HONER, M.; SCHUBIGER, P. Molecular imaging with PET. Chem Rev, v. 108, p. 1501-15016, 2008.
ALMUHAIDEB, A.; PAPATHANASIOU, N.; BOMANJI, J. 18F-FDG PET/CT Imaging in Oncology. Ann Saudi Med, v. 31(3), p. 3-13, 2011.
YU, S. Review of 18F-FDG Synthesis and Quality Control. Biomed Imaging Interv J, v. 2(4), p. e57, 2006.
ICH - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures: Text and Methodology Q2(R1). 2005. Available at: < https://www.ich.org/fileadmin /Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf>. Last accessed: 02 Oct. 2017.
COUNCIL OF EUROPE. European Pharmacopoeia, 9th ed. Strasbourg: Council of Europe, 2016.
THE UNITED STATES PHARMACOPEIA CONVENTION. The United States Pharmacopeia, 39th ed. Rockville: The United States Pharmacopeial Convention, 2016.
INMETRO - Instituto Nacional de Metrologia, Qualidade e Tecnologia. DOQ-CGCRE-008 - Orientação sobre validação de métodos analíticos. 2016. Available at: < http://www.inmetro.gov.br/Sidoq/Arquivos/CGCRE/DOQ/DOQ-CGCRE-8_05.pdf>. Last accessed: 02 Oct. 2017.
SOUZA, S.; JUNQUEIRA, R. A procedure to assess linearity by ordinary least squares method. Anal Chim Acta, v. 552, p. 25-35, 2005.
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