11C胆碱注射液离子色谱鉴别和放化纯度测定方法的建立

Establishment of Ion Chromatography Method for Identification and Determination of the Radiochemical Purity of 11CCholine Injection

  • 摘要: 正电子药物碳11C胆碱是PET/CT临床常用的肿瘤显像剂,对自行制备生产的碳11C胆碱注射液进行鉴别和放化纯度测定是保障药物安全有效的重要内容。本研究采用离子色谱串联放射性流动计数器(radio-IC-UV-flow-count)的方法,分离柱为Metrosep C 6-150/4.0强阳离子交换柱,流动相为含5%丙酮的6 mmol/L硝酸溶液,流速为0.9 mL/min的色谱条件。氯化胆碱标准液的阳离子峰保留时间为8.94 min,杂质Na+的保留时间为3.04 min,碳11C胆碱的放射性保留时间9.25 min,分离良好, 线性范围为10~100 mg·L–1,平均回收率在98.9%~102.1%,批内和批间变异均小于7.8%。 碳11C胆碱的放化纯度>95%,符合临床应用的要求,该方法简单、快速,适合半衰期极短的碳11C胆碱正电子放射性药物的鉴别和放化纯度的测定。

     

    Abstract: 11Ccholine is a normal tracer using for PET/CT, identification of 11Ccholine and analysis its radiochemical purity are important to guarantee the validity and safety of tracer. This study aims to establish a new, rapid and effective performance method for identification of 11Ccholine and analysis of the radiochemical purity in the products. The chromatographic method of radio-IC-flow-count were performed using a Metrosep C 6-150/4.0 column with mobile phase of 6 mmol/L HNO3+5% acetone aqueous solution, flow rate was 0.9 mL/min. The choline chloride and Na+ retention time were 8.94 min and 3.04 min, 11Ccholine were 9.25 min. The established separating method using IC-flow-count showed good efficiency, The linear range of calibration curves was 10–100 mg·L–1 for choline chloride, with the recovery rate ranged from 98.9% to 102.1% and the intrabatch and innerbatch variations of < 7.8%. The radio-IC-flow-count method is simple, valid and quick for the identification of 11Ccholine and analysis of radiochemical purity.

     

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