氯化铜[64Cu]溶液放射化学纯度的TLC测定方法研究

TLC investigation of the radiochemical purity of copper[^(64)Cu]chloride solution

通过对固定相和流动相等测试条件的筛选,建立一种快速简便的氯化铜[^(64)Cu]溶液放射化学纯度分析方法。该方法以含钾盐玻璃微纤维浸渍硅胶色谱纸(iTLC-SG)为固定相,二氯甲烷、乙腈、甲醇和0.05 mol∙L^(−1) HCl的混合溶液为流动相,氯化铜[^(64)Cu]溶液供试品主峰R_(f)值大于0.9,放射化学纯度大于95%,参比溶液主峰R_(f)值小于0.1,与供试品主峰分离度大于1.0,满足薄层色谱法(Thin-layer Chromatography,TLC)的系统适用性要求。建立的放射化学纯度分析方法满足欧洲药典对医用放射性核素溶液质量检验的技术要求,可实现快速、可靠的产品检验。

[Background]Copper[^(64)Cu]chloride solution is commonly used as raw material for the preparation of radiopharmaceuticals,which can be used in PET imaging or as a paired nuclide for tumor theranostic.Quality control test of copper[^(64)Cu]chloride solution for radiolabelling must be done before use,and the radiochemical purity test is the key item of quality control.[Purpose]This study aims to establish a rapid and reliable method for radiochemical purity analysis of copper[^(64)Cu]chloride solution,by screening the test conditions of stationary phase and mobile phase.[Methods]iTLC-SG silica gel paper plate was used as the stationary phase,and the mixed solution of dichloromethane,acetonitrile,methanol and 0.05 mol∙L^(−1) HCl was used as the mobile phase.The reference solution was prepared by mixing the test solution with DTPA solution in equal volume.The test solution and the reference solution were loaded on the paper plate separately and developed using the mobile phase.The kinds of stationary phase,composition and proportion of the mobile phase were optimized.[Results]Under the optimized conditions,the R_(f) of the test solution is greater than 0.9 and the R_(f) of the reference solution is less than 0.1,and the separation degree is greater than 1.0,which satisfies the system suitability of thin-layer chromatography(TLC).[Conclusions]Established method in this study is simple,reliable and rapid for the detection of radiochemical purity of copper[_(64)Cu]chloride solution,and complying with the technical requirements of European pharmacopoeia for the determination of radionuclide solution for radiolabelling.