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

摘要

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