Wang Min, Arkins Chase A, Zheng Qi-Huang, Glick-Wilson Barbara, Snyder Scott
Molecular Imaging Ligand Development Program, Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, USA.
Molecular Imaging Ligand Development Program, Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, USA.
Appl Radiat Isot. 2024 Oct;212:111444. doi: 10.1016/j.apradiso.2024.111444. Epub 2024 Jul 10.
A novel HPLC method was developed and validated to determine radiochemical identity, radiochemical purity and chemical purity for the analysis of O-(2-[F]fluoroethyl-l-tyrosine ([F]FET). In this method, an analytical Phenomenex Gemini C18 column was used with an isocratic eluent of 7 % ethanol and 93 % 50 mM potassium phosphate buffer (pH = 6.9). The flow rate was 1.0 mL/min and the injection volume was 10 μL. A photo-diode array detector set at 220 nm was used for UV mass detection and a single channel, high sensitivity radiation detector was used. The method validation assays including specificity, linearity, precision, accuracy, and robustness were evaluated. Results show that the method was suitable for qualitative and quantitative determination of radiochemical and chemical purity of [F]FET. This system has been routinely used for the analysis of more than 120 batches of [F]FET with radiochemical yield 23.7 ± 6 % (no decay corrected) and molar activity 593 ± 284 GBq/μmole in our facility to support human use.
开发并验证了一种新型高效液相色谱（HPLC）方法，用于测定O-(2-[F]氟乙基-L-酪氨酸（[F]FET）的放射化学特性、放射化学纯度和化学纯度。在该方法中，使用了Phenomenex Gemini C18分析柱，等度洗脱液为7%乙醇和93% 50 mM磷酸钾缓冲液（pH = 6.9）。流速为1.0 mL/min，进样体积为10 μL。使用设置在220 nm的光电二极管阵列检测器进行紫外质量检测，并使用单通道高灵敏度辐射检测器。对包括特异性、线性、精密度、准确度和稳健性在内的方法验证试验进行了评估。结果表明，该方法适用于[F]FET放射化学和化学纯度的定性和定量测定。在我们的机构中，该系统已常规用于分析120多批次的[F]FET，其放射化学产率为23.7±6%（未进行衰变校正），摩尔活度为593±284 GBq/μmole，以支持人体使用。
