Rapid detection of the residual kryptofix 2.2.2 levels in [18F]-labeled radiopharmaceuticals by ultra-performance liquid chromatography tandem mass spectrometry

摘要

A fast and sensitive ultra-performance liquid chromatography-tandem mass spectrometric (UPLClMSlMS) method was developed and validated for determination of the residual levels of Kryptofix 2.2.2 (K222) in [18F]-labeled radiopharmaceuticals. The analytical time was only 3 min, and the injection volume was 5 μL. An electrospray ionization source was used in the positive mode (ESI+) for UPLC/MS/MS. The analytical measurements were performed in the multiple reaction monitoring (MRM) mode. The calibration curve at the spiked concentrations of 2-500 ng/mL for K222 showed good linearity. The intraand inter-day precisions were not more than 5%. The accuracy satisfied the requirement of quality control analysis, the recoveries were found to be 80-120%. This method was successfully applied to detect the residue of K222 in [18F]-fluorodeoxyglucose [(18F)FDG], [18F]-fluoromisonizole[(18F)FMISO], 3'-deoxy-3'-[18F]-fluorothymidine [(18F)FLT], and two new [18F]-labeled radiopharmaceuticals 4-[-(2-[18F]fluoroethoxy) methyl]-1- [2-(2-methyl-5-nitro-1H- imidazol-1-yl) ethyl]-1H-1,2,3-triazole (named as 18F-BNU-1) and 4-[-(2-[18F] fluoroethoxy) methyl]-1-[2-(2-nitro-1H-imidazol-1-yl) ethyl]-1H- 1,2,3-triazole (named as 18F-BNU-2) produced in our lab.