Radiochemical purity determination of technetium (99m)Tc-sestamibi by high performance liquid chromatography (HPLC)

• Autor(a) principal: MARTINS, PATRICIA de A.
• Data de Publicação: 2020
• Outros Autores: FUKUMORI, NEUZA T.O., SILVA, NATANAEL G. da, MATSUDA, MARGARETH M.N., INTERNATIONAL NUCLEAR ATLANTIC CONFERENCE
• Tipo de documento: Artigo de conferência
• Título da fonte: Repositório Institucional do IPEN
• Texto Completo: http://repositorio.ipen.br/handle/123456789/30588
• topic: high-performance liquid chromatography; quality control; radiochemical analysis; single photon emission computed tomography; technetium 99

The assessment of the extent of reversible or irreversible mitochondrial damage after myocardial ischemia is performed by obtaining myocardial perfusion SPECT-CT images of Technetium-99m Sestamibi radiopharmaceutical (99mTc-2-methoxy-isobutyl-isonitrile; 99mTc-sestamibi; 99mTc-MIBI). For quality control purposes, the monograph of the United States Pharmacopoeia (USP) was followed. The determination of the radiochemical purity of 99mTc-sestamibi involves the use of two chromatographic methods: thin layer chromatography in reverse phase and high performance liquid chromatography. This work aims to determine the radiochemical purity of 99mTc-sestamibi by the HPLC method described in USP. The analyses were performed on a Shimadzu liquid chromatography, LC-20AT model, consisting of two pumps, degasser, automatic sample injector, UV-visible detector and Bioscan radioactivity detector. The column used was ??Bondapack C18 (3.9 x 300 mm, 10 ??m, Waters) and the mobile phase was a mixture of acetonitrile, 0.05 mol L-1 ammonium sulfate and methanol (20:35:45). 5 ??L of sample (approximately 250 ??Ci) was injected with a 2 mL min-1 mobile phase flow. According to the USP monograph, the retention time for 99mTc-sestamibi is 5-10 minutes and for the 99mTc-pentamibidimethylvinylisonitrile impurity is 6-13 minutes. Not less than 90% of the total radioactivity must be present as 99mTc-sestamibi and not more than 5% as 99mTc-pentamibidimethylvinylisonitrile. For 12 analyzed batches of MIBI-TEC?? produced at IPEN/CNEN-SP, the product presented a retention time of 7 minutes and the 99mTc-pentamibidimethylvinylisonitrile impurity formation was not observed.