Analytical hplc
AssigneeGe Healthcare Limited
InventorsAlan Clarke, Petrus Hendrik Engelbrecht, Julian Grigg, Imtiaz Ahmed Khan, Kristine Wikene, Graeme McRobbie
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Abstract
The present invention concerns a HPLC separation method useful in the synthesis of [18F]-labelled compounds, including positron emission tomography (PET) tracers. The method of the invention addresses constraints of previous methods imposed by the needs of free 5 [18F]fluoride. The present invention provides a simplified process that enables rapid separation and analysis of free [18F]fluoride and chemical impurities in the synthesis of [18F]-labelled compounds.
Claims21
A method of analysing radiochemical purity and chemical impurities in a radiopharmaceutical composition, using reversed phase HPLC, wherein the radiopharmaceutical composition comprises a compound or a pharmaceutically acceptable salt thereof, labelled with [18F], and wherein said method comprises:
- (a) providing a sample of the radiopharmaceutical composition to an HPLC column while a mobile phase is water, or water and organic solvent, or a neutral pH buffer, or a neutral pH buffer and organic solvent;
- and subsequently
- (b) providing a different mobile phase comprising an acid modifier, water and organic solvent to the HPLC column.
Dependencies are inferred from the claim text.