Determination of ionic 68Ga impurity in radiopharmaceuticals: major revision of radio-HPLC methods

Determination of purity of 68 Ga-radiopharmaceuticals is an extremely important part of quality control in routine clinical practice as well as during R&D of 68 Ga-radiopharmaceuticals. HPLC results do not always match TLC results. This uncertainty most likely comes from nonspecific sorption of...

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Bibliographic Details
Published inJournal of radioanalytical and nuclear chemistry Vol. 323; no. 1; pp. 189 - 195
Main Authors Maruk, Alesya Ya, Larenkov, Anton A.
Format Journal Article
LanguageEnglish
Published Cham Springer International Publishing 2020
Springer Nature B.V
Subjects
Chemistry
Chemistry and Materials Science
Citric acid
Diagnostic Radiology
Hadrons
Heavy Ions
Inorganic Chemistry
Nuclear Chemistry
Nuclear Physics
Physical Chemistry
Quality control
TLC
Ga
Quality control of radiopharmaceuticals
HPLC
Citric acid
Radiochemical purity
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Summary:Determination of purity of 68 Ga-radiopharmaceuticals is an extremely important part of quality control in routine clinical practice as well as during R&D of 68 Ga-radiopharmaceuticals. HPLC results do not always match TLC results. This uncertainty most likely comes from nonspecific sorption of ionic 68 Ga on C18 phase. The aim of this study was to develop reliable HPLC analysis procedure. It was shown that simple replacement of trifluoroacetic acid in the eluent with citric acid results into change of the results obtained using HPLC analysis.
ISSN:0236-5731
1588-2780
DOI:10.1007/s10967-019-06964-1