用于P2X7受体靶向性[C]GSK1482160放射性药物的放射性高效液相色谱法的开发、验证及应用
Development, validation and implementation of radio-HPLC methods for the P2X7-receptor-targeted [C]GSK1482160 radiopharmaceutical.
作者信息
Wissmann Carmen L, Wang Min, Gao Mingzhang, Zheng Qi-Huang, Green Mark A
机构信息
Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, USA.
Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, USA.
出版信息
Appl Radiat Isot. 2018 Dec;142:8-11. doi: 10.1016/j.apradiso.2018.09.007. Epub 2018 Sep 8.
A radio-analytical RP-HPLC method was developed and validated to support production of the P2X7-receptor-targeted [C]GSK1482160 radiopharmaceutical. Method validation included characterization of retention times, peak shapes, linearity, accuracy, precision, selectivity, limits of detection and quantitation (UV signal), radiochemical stability, as well as analytical method range and robustness. The validated radio-HPLC method is suitable for the definition of [C]GSK1482160 radiochemical identity, radiochemical purity, as well as molar activity, and is being employed in support of human studies with [C]GSK1482160.
开发并验证了一种放射性分析反相高效液相色谱法（RP-HPLC），以支持生产靶向P2X7受体的[C]GSK1482160放射性药物。方法验证包括保留时间、峰形、线性、准确度、精密度、选择性、检测限和定量限（紫外信号）、放射化学稳定性以及分析方法范围和稳健性的表征。经验证的放射性高效液相色谱法适用于定义[C]GSK1482160的放射化学特性、放射化学纯度以及摩尔活度，并用于支持[C]GSK1482160的人体研究。
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