单系统纸层析法测定99mTc-DTPA放射化学纯度

M. Maskur, E. Lestari, Amal Rezka Putra, D. Kurniasih, E. Sarmini, Yayan Tahyan, A. Gunawan, A. Aries
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引用次数: 1

摘要

由于99mTc的半衰期较短,约为6.0小时,因此需要更高效和有效的99mTc- dtpa质量控制技术。我们成功地开发了一套快速实用的放射化学纯度检测系统。两体系TLC法用于放射化学纯度检测,以甲乙基酮为流动相,以0.9%氯化钠溶液为流动相。一体系法以丙酮和0.9%氯化钠混合溶液为流动相。本研究成功建立了以Whatman-1纸固定相和丙酮- 0.9%氯化钠溶液的混合流动相为流动相的薄层色谱单体系放射化学纯度测定方法。流动相为丙酮:0.9%氯化钠,比例为9:1,效果最佳。该相可将99mTc-DTPA (Rf = 0.4-0.6)与99mTcO4- (Rf = 0.9-1.0)和99mTcO2 (Rf = 0.0-0.1)作为放射化学杂质分离。结果表明,单体系TLC法可用于99mTc-DTPA放射性药物试剂盒的放射化学纯度检测。该方法可以将产物化合物(99mTc-DTPA)与杂质(99mTcO2和99mTcO4-)完全分离。
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Determination of Radiochemical Purity of 99mTc-DTPA Using One-System Method of Paper Chromatography
The more efficient and effective quality control techniques for 99mTc-DTPA are needed because 99mTc has a short half-life of around 6.0 hours. We have succeeded in developing a one-system of Thin Layer Chromatography (TLC) for radiochemical purity testing system that is faster and more practical. Two-system method of TLC for radiochemical purity testing uses mobile phase of methyl ethyl ketone indicated as system A and 0.9% sodium chloride solution indicated as system B. One-system method uses the mobile phase of a mixture solution of acetone and 0.9% sodium chloride. In this study, the determination of radiochemical purity of the one-system of TLC has been successfully developed using the Whatman-1 paper stationary phase and the mixture of mobile phase between acetone and 0.9% sodium chloride solution. The mobile phase of acetone: 0.9% sodium chloride with a ratio of 9:1 shows the most optimum results. This phase can separate 99mTc-DTPA (Rf = 0.4-0.6) from 99mTcO4- (Rf = 0.9-1.0) and 99mTcO2 (Rf = 0.0-0.1) as radiochemical impurities. This result shows that the one-system of TLC method can be used for radiochemical purity testing of 99mTc-DTPA radiopharmaceutical kits. This method can completely separate the product compound (99mTc-DTPA) from its impurities (99mTcO2 and 99mTcO4-).
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