会議発表用資料 Measurement of the molar radioactivity for [11C]choline and [11C]AIB without UV chromophores using radio-HPLC coupled with a corona-charged aerosol detector to comply with GMP

Kawamura, Kazunori  ,  Hashimoto, Hiroki  ,  Furutsuka, Kenji  ,  Takei, Makoto  ,  Kariya, Kaori  ,  Shiomi, Satoshi  ,  Fujishiro, Tomoya  ,  Nengaki, Nobuki  ,  Muto, Masatoshi  ,  Ming-Rong, Zhang

2017-05-15
内容記述
Objectives: The most common detection technique for analytical HPLC is ultraviolet (UV) detection. However, it is difficult to detect low or no UV chromophore molecules such as amino acid derivatives and choline using HPLC-UV system. Low mass of these compounds has been measured by derivatization and alternative detection methods, such as refractive index, electrochemical detection and mass spectrometry, and corona-charged aerosol detection (CAD). CAD is a mass-based detection that provides a sensitive and near universal response for any nonvolatile compounds independent of chemical composition [1]. CAD can detect the mass unseen by UV absorption, and is well suited for the underivatized detection of compounds without UV chromophores and the quantification of unknowns [1]. To easily and rapidly measure the molar radioactivity of 11C-labeled PET probe without UV chromophores such as amino acid derivatives and choline, we developed radio-HPLC coupled with CAD (radio-HPLC-CAD system). Also, we validated measurement of the molar radioactivity of [11C]choline and [11C]AIB to comply with GMP.Methods: The molar radioactivity of [11C]choline and [11C]AIB was determined to measure the mass using radio-HPLC-CAD (HPLC system: Ultimate 3000, Thermo Fisher Scientific; Radioactivity detector: Gabi Star PET, Raytest; CAD: Corona Veo, Thermo Fisher Scientific), radioactivity using dose calibrator and weight. Quantitative analyses for the mass of [11C]choline and [11C]AIB were validated according to the validation protocols.Results: We enabled detecting the mass of [11C]choline and [11C]AIB using the radio-HPLC-CAD system, and calculate the molar radioactivity of [11C]choline and [11C]AIB (approximately 100 and 50 GBq/μmol at end of synthesis, respectively). The mass of [11C]choline was measured with a good linearity in the range of 0.2 to 20 μg/mL (R2>0.98), accuracy within the range of 90 to 110%, repeatability on three injections at the same day or three different days in less than 5% relative standard deviation (% RSD). Also, the mass of [11C]AIB was measured with a good linearity in the range of 0.1 to 10 μg/mL (R2>0.98), accuracy within the range of 90 to 110%, repeatability on three injections at the same day or three different days in less than 5% RSD.
22th International Symposium on Radiopharmaceutical Sciences

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