Determination of ionic 68Ga impurity in radiopharmaceuticals: major revision of radio-HPLC methods
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Determination of purity of 68Ga-radiopharmaceuticals is an extremely important part of quality control in routine clinical practice as well as during R&D of 68Ga-radiopharmaceuticals. HPLC results do not always match TLC results. This uncertainty most likely comes from nonspecific sorption of ionic 68Ga 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.
KeywordsHPLC TLC 68Ga Quality control of radiopharmaceuticals Radiochemical purity Citric acid
The reported study was partly funded by Russian Foundation for Basic Research, Project No. 19-33-70048.
Compliance with ethical standards
Conflict of interest
The authors declare no conflict of interest.
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