Romanian Society of Pharmaceutical Sciences
 

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INFLUENCE OF THE SEPARATION PARAMETERS APPLIED FOR DETERMINATION OF IMPURITIES FDG AND CLDG

MIRELA MIHON1,2, CATALIN STELIAN TUTA2, ALINA CATRINEL ION1, JACEK KOZIOROWSKI3, DANA NICULAE2, VASILE LAVRIC1, DOINA DRĂGĂNESCU2.4*

1.“Politehnica” University of Bucharest, Faculty of Applied Chemistry and Materials Science, 1-7 Polizu Street, RO-011061, Bucharest, Romania
2 .“Horia Hulubei” National Institute for Physics and Nuclear Engineering, 30 Reactorului Street, Măgurele, Ilfov, Romania
3 .Department of Radiation Physics and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden
4 .“Carol Davila” University of Medicine and Pharmacy, Faculty of Pharmacy, 6 Traian Vuia Street, RO-020956, Bucharest, Romania

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2-fluoro-2-deoxy-D-glucose (FDG) and 2-chloro-2-deoxy-D-glucose (ClDG) are chemical impurities found in the 2-[18F]fluoro-2-deoxy-D-glucose products (18F-FDG). The objective of this study was to find the best condition for the separation of FDG and ClDG, evaluating different columns under various operating conditions. Chromatographic parameters such as column temperature, composition and flow rate of the mobile phase were the independent variables used in the optimization process. The optimized method was validated and validation results showed a good accuracy, repeatability and reproducibility.