Establishment of Thin Layer Chromatographic Method for Determination of Radiochemical Purity of Technetium[99mTc] Methylenediphosphonate Injection

To establish a reliable method for measuring the radiochemical purity of technetium[99mTc] methylenediphosphonate injection, analysis conditions such as stationary phase and developing solvent were studied. The analytical method was methodologically verified in accordance with the Chinese Pharmacopo...

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Bibliographic Details
Published inTong wei su Vol. 36; no. 6; pp. 589 - 597
Main Author WANG Yong, LIANG Su, CUI Xiaoyan, JIANG Hua, ZHANG Yun, YANG Liu
Format Journal Article
LanguageChinese
Published Editorial Board of Journal of Isotopes 01.12.2023
Subjects
polyamide-6 thin-layer plate
radiochemical purity
technetium[99mtc] methylenediphosphonate injection
thin-layer chromatography
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Summary:To establish a reliable method for measuring the radiochemical purity of technetium[99mTc] 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 chromatography, 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 solution was used as the developing solvent, could improve the tailing problem of the main peak of technetium[99mTc] methylenediphosphonate injection. The resolution of radioactive main peak and potential impurities including pertechnetate[99mTc] and colloidal technetium[99mTc] 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
ISSN:1000-7512