title: Simultaneous analysis of FDG, ClDG and Kryptofix 2.2.2 in [18F]FDG preparation by high-performance liquid chromatography with UV detection.
abstract: A practical, sensitive and rapid analytical method was established and validated for chemical impurity tests of 2-deoxy-2-fluoro-d-glucose (FDG), 2-deoxy-2-chloro-d-glucose (ClDG) and Kryptofix 2.2.2 (K-222) in [18F]FDG. This method was based on precolumn derivatization with ultraviolet (UV) detection. FDG and ClDG were rapidly derivatized with 1-phenyl-3-methyl-5-pyrazolone in the presence of borate buffer at 40 degrees C, and the labeled derivatives and K-222 were separated by reversed-phase high-performance liquid chromatography and monitored by UV absorbance at 210 nm. After optimization of the conditions, FDG, ClDG and K-222 could be determined within 15 min and showed good performance in terms of sensitivity, linearity and reproducibility. This method could be successfully applied to the quality control test of [18F]FDG produced by a commercially available apparatus.
authors.affiliation: Molecular Imaging Center, National Institute of Radiological Sciences, 4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan. nakaor@nirs.go.jp
authors.forename: Ryuji
authors.initials: R
authors.lastname: Nakao
authors.forename: Takehito
authors.initials: T
authors.lastname: Ito
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Yamaguchi
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Suzuki
mesh_terms: D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003847:Deoxyglucose / Q000031:analogs & derivatives* / Q000032:analysis / Q000528:radiation effects; D004355:Drug Stability; D019788:Fluorodeoxyglucose F18 / Q000032:analysis* / Q000528:radiation effects; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000528:radiation effects; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000032:analysis / Q000528:radiation effects; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D013237:Stereoisomerism
chemical_list: D019086:Bridged Bicyclo Compounds, Heterocyclic; D004364:Pharmaceutical Preparations; D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18; C078464:2-chloro-2-deoxyglucose; C006071:cryptating agent 222; D003847:Deoxyglucose