同位素2023，Vol.36Issue(6)：589-597,9.DOI:10.7538/tws.2023.youxian.024
锝[99mTc]亚甲基二膦酸盐注射液中放化纯度薄层色谱分析方法的建立
Establishment of Thin Layer Chromatographic Method for Determination of Radiochemical Purity of Technetium[99m Tc]Methylenediphosphonate Injection
王勇 1梁塑 1崔晓艳 1姜华 1张云 1杨柳1
作者信息
- 1. 原子高科股份有限公司,北京 102413
- 折叠
摘要
Abstract
To establish a reliable method for measuring the radiochemical purity of tech-netium[99m Tc]methylenediphosphonate injection,analysis conditions such as stationary phase and developing solvent were studied.The analytical method was methodologically verified in accordance with the Chinese Pharmacopoeia and other relevant provisions.The results showed that the analytical method of single-system thin-layer chromatogra-phy,in which polyamide-6 thin-layer plate was used as the stationary phase,V(1 mol/L sodium acetate solution):V(0.1 mol/L hydrochloric acid solution)= 1∶1 mixed solu-tion was used as the developing solvent,could improve the tailing problem of the main peak of technetium[99m Tc]methylenediphosphonate injection.The resolution of radioac-tive main peak and potential impurities including pertechnetate[99m Tc]and colloidal technetium[99m Tc]was greater than 1.0.The method had a good linear relationship in the radioactivity range of 2.7×10-2 μCi to 42.4 μCi,and the correlation coefficient r was 0.997,with good specificity,good durability and intermediate precision.Compared with the analytical method of the pharmacopoeias,the relative error of radiochemical purity met the requirement of less than 2.0%.The established thin-layer chromatogra-phy is suitable for determination of the radiochemical purity of technetium[99m Tc]meth-ylenediphosphonate injection.关键词
锝[99mTc]亚甲基二膦酸盐注射液/放化纯度/聚酰胺-6薄层板/薄层色谱法Key words
technetium[99m Tc]methylenediphosphonate injection/radiochemical purity/polyamide-6 thin-layer plate/thin-layer chromatography分类
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王勇,梁塑,崔晓艳,姜华,张云,杨柳..锝[99mTc]亚甲基二膦酸盐注射液中放化纯度薄层色谱分析方法的建立[J].同位素,2023,36(6):589-597,9.
