Journal of Pharmaceutical and Biomedical Analysis 2014-06-01

The separation and detection of PET tracers via capillary electrophoresis for chemical identity and purity analysis.

Shilin Cheung, Jimmy Ly, Mark Lazari, Saman Sadeghi, Pei Yuin Keng, R Michael van Dam

Index: J. Pharm. Biomed. Anal. 94 , 12-8, (2014)

Full Text: HTML

Abstract

CE coupled with UV detection was assessed as a possible platform for the chemical identity and purity analysis of positron emission tomography (PET) tracers using [(18)F]FAC and [(18)F]FLT as examples. Representative samples containing mixtures of the tracers plus well-known impurities, as well as real radioactive samples (formulated for injection), were analyzed. Using MEKC with SDS in a neutral phosphate buffer, the separation of all compounds in the samples was achieved with baseline resolutions in less than 4.5min and 3min for FLT and FAC samples, respectively. In comparison to the gold-standard for chemical analysis (i.e. HPLC/UV), we have demonstrated improvements in analysis times, and comparable LOD. Although the reproducibility in migration time is slightly lower than that of the HPLC, identification of the compounds was still possible due to good peak separation. In addition, we show that CE can be used to identify and quantify Krytofix2.2.2 (a toxic and commonly used phase transfer catalyst) in less than 2min and with a LOD of 45μg/mL (non-optimized). These results demonstrate adequate performance for chemical identity and purity analysis. Combined with the potential for miniaturization into a microchip format, these results suggest the potential of CE as an integral part of a miniaturized quality control system for PET tracers. Copyright © 2014 Elsevier B.V. All rights reserved.