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A mild anion-exchange HPLC method for analysis of [18F]sodium fluoride solution for injection

Journal 2020 · IF 1.137 · 326(1): 575-581 · 发表于 2020 年 8 月 28 日
作者: Cai Fei,Yan Heng,Fan Wenbin,Li Shihong,Xu Jianfeng,Wang Zheng,Tang Xiaobin
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摘要

A mild HPLC method for the quality control of [ 18 F]sodium fluoride solution for injection was developed. The method used anion exchange column for separation, UV and online radio-detectors for fluoride content and fluorine-18 determination. A mixture of 100 mM sodium acetate and 25 mM sodium chloride was chosen as mobile phase. The method was validated for system suitability, specificity, fluoride concentration and radiochemical purity determination with good linearity, accuracy and precision. The good robustness of the system was also verified, enabling routine analysis of fluoride content and radiochemical purity of the [ 18 F]sodium fluoride product.