Ultra-fast liquid chromatography method coupled with ultraviolet detection to quantify dimethylsulfoxide, dimethylformamide and dimethylacetamide in short half-lives radiopharmaceuticals,Journal of Labelled Compounds and Radiopharmaceuticals

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Ultra-fast liquid chromatography method coupled with ultraviolet detection to quantify dimethylsulfoxide, dimethylformamide and dimethylacetamide in short half-lives radiopharmaceuticals
Journal of Labelled Compounds and Radiopharmaceuticals ( IF 0.9 ) Pub Date : 2021-08-05 , DOI: 10.1002/jlcr.3938
Julien Fouque ₁ , Timofei Rusu ₂ , Samuel Huguet ₁ , Emilie Da Costa Branquinho ₁ , Sandy Blondeel‐Gomes ₁ , Keyvan Rezaï ₁ , Olivier Madar ₁

Affiliation

Radiolabelling with short half-lives radionuclides (e.g., fluorine-18 and carbon-11) must be as efficient and as fast as possible. Nucleophilic radiofluorinations and radiomethylations are conducted in polar aprotic solvents, such as dimethylsulfoxyde (DMSO), N,N-dimethylformamide (DMF) and N,N-dimethylacetamide (DMA), at high temperature. Those solvents are classified as toxic according to the ICH guidelines and must be evaluated in drug such as radiopharmaceuticals. Headspace gas chromatography is the standard method for the quantification of residual solvents but is not optimized for a rapid quantification of low vapor pressure solvents such as DMSO, DMF and DMA in radiopharmaceuticals. Direct injection gas chromatography is an interesting option without incubation step but the analysis run-time remains beyond 10 min long. In consequence, we developed a very simple ultra-high performance liquid chromatography method coupled with UV detection. Following the EMA requirements, we successfully validated a 3-min run-time analysis for quantification of three solvents in short half-lives radiopharmaceuticals. We currently use this method for the quality control of radiopharmaceuticals produced in our PET center.

中文翻译：

超快速液相色谱法结合紫外检测定量短半衰期放射性药物中的二甲基亚砜、二甲基甲酰胺和二甲基乙酰胺

用半衰期短的放射性核素（例如氟 18 和碳 11）进行放射性标记必须尽可能高效和快速。亲核放射性氟化和放射性甲基化在极性非质子溶剂中进行，例如二甲基亚砜 (DMSO)、N,N-二甲基甲酰胺 (DMF) 和 N,N-二甲基乙酰胺 (DMA)，在高温下进行。根据 ICH 指南，这些溶剂被归类为有毒，必须在放射性药物等药物中进行评估。顶空气相色谱法是残留溶剂定量的标准方法，但并未针对放射性药物中的 DMSO、DMF 和 DMA 等低蒸气压溶剂的快速定量进行优化。直接注射气相色谱是一种有趣的选择，无需孵育步骤，但分析运行时间仍超过 10 分钟。结果，我们开发了一种非常简单的超高效液相色谱结合 UV 检测的方法。遵循 EMA 要求，我们成功验证了 3 分钟的运行时间分析，用于量化短半衰期放射性药物中的三种溶剂。我们目前使用这种方法对我们 PET 中心生产的放射性药物进行质量控制。

更新日期：2021-09-13

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