Quality control of PET radiopharmaceuticals by high‐performance liquid chromatography with tris(2,2′‐bipyridyl)ruthenium(II) electrogenerated chemiluminescence detection

Abstract

A highly sensitive reversed-phase liquid chromatographic (HPLC) method was investigated to analyze a range of positron emission tomography (PET) radiopharmaceuticals using electrogenerated chemiluminescence (ECL) detection. ECL is based on the reaction of PET molecules with tris(2,2'-bipyridyl)ruthenium(III) [Ru(bpy)(3)(3+)], which is generated through the on-line electro-oxidation of Ru(bpy)(3)(2+). In 21 different radiopharmaceuticals studied, 18 compounds could be detected with detection limits (signal-to-noise ratio = 3) of 0.12-72 ng/mL per 20 microL injection. Sufficient reproducibility and linearity were obtained for the quantitative determination of PET molecules in pharmaceutical fluid. This method could be successfully applied to quality control tests of PET radiopharmaceuticals with ultra-high specific radioactivity.

Use of LC‐MS for the quality control of radiopharmaceuticals: example of [18F]ML10

“…Because LC‐MS provides the molecular weight of the compound detected, identity and purity can be proven in a single experiment, halving the time necessary for the analysis and represents an improvement in the QC of radiopharmaceuticals. This methodology could also be applied in the QC of very high specific activity radioligands, where UV would not represent a suitable method of analysis …”

PET probes for imaging brain acetylcholinesterase

“…These methods dramatically improved the detection limit to a level of several ng/mL. The detection limits of MP4A and MP4P in particular were reduced to 1.2 and 0.71 ng/mL, respectively, using the electrogenerated chemiluminescence method …”