Ultra-performance liquid chromatographic technique was applied for the first time for determination of radiochemical and chemical purity of [11C]methionine with measurement time less than 2 min. The pH and eluent strength of mobile phase were optimized to achieve a gradient elution for separation of non-radioactive impurities as well as radioactive ingredients. The developed method was validated according to the following parameters: linearity, repeatability, recovery, limit of quantitation. The novel chromatographic procedure with reduced measurement time could be uniquely applied for the quality control of [11C]methionine to considerably shorten the release time and avoid radioactivity loss of radiopharmaceutical.

中文翻译：

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UPLC技术快速液相色谱法测定[11C]蛋氨酸的放射化学和化学纯度

首次应用超高效液相色谱技术测定[11C]蛋氨酸的放射化学和化学纯度，测定时间小于2 min。对流动相的 pH 值和洗脱液强度进行了优化，以实现用于分离非放射性杂质和放射性成分的梯度洗脱。根据以下参数对开发的方法进行验证：线性、重复性、回收率、定量限。减少测量时间的新型色谱方法可独特地应用于[11C]蛋氨酸的质量控制，以显着缩短释放​​时间并避免放射性药物的放射性损失。