UĞur Ayşe, ElÇİ Şükrü Gökhan, YÜksel Doğangün
Department of Nuclear Medicine, Pamukkale University, Education and Research Hospital, Denizli Turkey.
Department of Biomedical Engineering, Faculty of Technology, Pamukkale University, Denizli Turkey.
Turk J Chem. 2021 Feb 17;45(1):26-34. doi: 10.3906/kim-2003-19. eCollection 2021.
The prostate-specific membrane antigen (PSMA) represents an ideal biomarker for molecular imaging. Various PSMA-targeted radioligands are available for prostate cancer imaging. In this study, labeling of PSMA I&T with Ga, as well as validation of the radiochemical purity of the synthesis product by reverse phase radio high-performance liquid chromatography (HPLC) method are intended. Since the standard procedure for the quality control (QC) was not available, definition of chemical and radiochemical purity of Ga-PSMA I&T was carried out according to the Q2 (R1) ICH guideline. The standard QC tests were analyzed with Scintomics 8100 radio-HPLC system equipped with a radioactivity detector. The method was evaluated in terms of linearity, precision and accuracy, LOQ, robustness parameters, and specificity. To assess the radiochemical and chemical purity of Ga-PSMA I&T, the developed method was validated to apply safely to patients. An excellent linearity was found between 1μg/mL and 30 μg/mL, with a limit of detection and limit of quantitation of 0.286 μg/mL and 0.866 μg/mL, respectively for Ga-PSMA I&T. The recovery was 96.8 ± 3.8%. The quality control of the final product was performed many times with validated radio-HPLC method and was found to comply with ICH requirements, thus demonstrating the accuracy and robustness of the method for routine clinical practice.
前列腺特异性膜抗原（PSMA）是分子成像的理想生物标志物。多种靶向PSMA的放射性配体可用于前列腺癌成像。在本研究中，旨在用镓标记PSMA I&T，并通过反相放射性高效液相色谱（HPLC）法验证合成产物的放射化学纯度。由于尚无质量控制（QC）的标准程序，因此根据ICH Q2（R1）指南对Ga-PSMA I&T的化学和放射化学纯度进行了定义。使用配备放射性检测器的Scintomics 8100放射性HPLC系统分析标准QC测试。从线性、精密度、准确度、定量限、稳健性参数和特异性方面对该方法进行了评估。为评估Ga-PSMA I&T的放射化学和化学纯度，对所开发的方法进行了验证，以安全应用于患者。对于Ga-PSMA I&T，在1μg/mL至30μg/mL之间发现了出色的线性，检测限和定量限分别为0.286μg/mL和0.866μg/mL。回收率为96.8±3.8%。使用经过验证的放射性HPLC方法对最终产品进行了多次质量控制，发现其符合ICH要求，从而证明了该方法在常规临床实践中的准确性和稳健性。
