Tayal Sachin, Gurjar Murari, Shukla Varun, Venkatachalam Manikandan Marappagounder, Kumar Rohit, Jain Yash
Department of Nuclear Medicine and Molecular Imaging, Homi Bhabha Cancer Hospital and Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Tata Memorial Centre, Homi Bhabha National Institute, Varanasi, Uttar Pradesh, India.
Indian J Nucl Med. 2024 Jul-Aug;39(4):265-271. doi: 10.4103/ijnm.ijnm_42_24. Epub 2024 Nov 18.
Prostate-specific membrane antigen (PSMA) has shown to be a promising agent for prostate cancer imaging under PET-CT. With the automation in radiolabeling with 68Ga, using iTG 68Ge/68Ga generator, it has helped introduce various new diagnostic agents and achieve good manufacturing practices (GMP) simultaneously. However, before any radiopharmaceutical is put into clinical usage, it should always be checked for its radiochemical purity and other quality parameters before injecting in the patient. Chromatography techniques such as Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), and Thin-Layer Chromatography (TLC) are the most frequently utilized separation technique for purity analysis. A rapid quality control HPLC based methodology was required for radiopharmaceuticals.
AIM & OBJECTIVE: In our current setting, we conducted quality control analysis and standardized and validated HPLC method for the routine quality check of 68Ga-PSMA-11.
The QC of 68Ga PSMA-11 was performed under ITLC and HPLC.
Linearity, accuracy, precision and specificity were assessed and quantified in accordance with International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (Q2 (R1) ICH) guidelines, which can be implemented in resource-limited settings to check the quality.
The current HPLC based methodology is rapid, with a retention time of 2.24 min, rendering it a favorable analytical standard operating procedure for QC analysis of 68Ga-PSMA-11.
前列腺特异性膜抗原（PSMA）已被证明是正电子发射断层扫描-计算机断层扫描（PET-CT）下前列腺癌成像的一种有前景的试剂。随着使用iTG 68Ge/68Ga发生器进行68Ga放射性标记的自动化，它有助于引入各种新的诊断试剂并同时实现良好生产规范（GMP）。然而，在任何放射性药物投入临床使用之前，在注射给患者之前，都应始终检查其放射化学纯度和其他质量参数。气相色谱（GC）、高效液相色谱（HPLC）和薄层色谱（TLC）等色谱技术是最常用于纯度分析的分离技术。放射性药物需要一种基于快速质量控制HPLC的方法。
在我们当前的情况下，我们对68Ga-PSMA-11进行了质量控制分析，并标准化和验证了用于常规质量检查的HPLC方法。
68Ga PSMA-11的质量控制在离子交换薄层色谱（ITLC）和HPLC下进行。
根据人用药品注册技术要求国际协调会议（Q2（R1）ICH）指南评估和量化了线性、准确性、精密度和特异性，该指南可在资源有限的环境中实施以检查质量。
当前基于HPLC的方法快速，保留时间为2.24分钟，使其成为68Ga-PSMA-11质量控制分析的有利分析标准操作规程。
