Borré María Candela, Tesán Fiorella C, Leonardi Natalia M, Zubillaga Marcela B, Salgueiro M Jimena
Radioisotope Laboratory, Physics Department, School of Pharmacy and Biochemistry, University of Buenos Aires, Junín 956 PB, Buenos Aires (C1113AAD), Argentina.
Appl Radiat Isot. 2013 Dec;82:322-4. doi: 10.1016/j.apradiso.2013.09.007. Epub 2013 Oct 3.
[(99m)Tc]pentetate ([(99m)Tc]DTPA) is the most commonly used radiopharmaceutical renography agent. The aim of this work was to validate an alternative method for assessing [(99m)Tc]DTPA radiochemical purity (RCP), according to the ICH Q2(R1) guidance: "Validation of Analytical Procedures". The proposed method is composed of two chromatographic systems. System A is a miniaturized system of thin layer chromatography (TLC) silica gel impregnated aluminum strips as stationary phase (SP) and distilled water as mobile phase (MP). System B consists of Whatman 1 paper strips as SP and methyl ethyl ketone as MP. Results indicate that the proposed RCP method has been validated, as it is specific, precise, accurate, linear and robust. Therefore, it can be used as an alternative method for RCP quality control purposes and as stability indicator as well.
[(99m)Tc]喷替酸盐([(99m)Tc]二乙三胺五乙酸)是最常用的放射性药物肾造影剂。本研究的目的是根据国际人用药品注册技术协调会(ICH)Q2(R1)指南“分析方法验证”,验证一种评估[(99m)Tc]二乙三胺五乙酸放射化学纯度(RCP)的替代方法。所提出的方法由两个色谱系统组成。系统A是一个小型化的薄层色谱(TLC)系统,以硅胶浸渍铝条为固定相(SP),蒸馏水为流动相(MP)。系统B由沃特曼1号纸条作为固定相和甲乙酮作为流动相组成。结果表明,所提出的RCP方法已得到验证,因为它具有特异性、精密度、准确性、线性和稳健性。因此,它可以用作RCP质量控制目的的替代方法,也可以作为稳定性指标。