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Radiochemical purity determination of technetium (99m)Tc-sestamibi by high performance liquid chromatography (HPLC)
Registro en:
0000-0003-4455-3486
Autor
MARTINS, PATRICIA de A.
FUKUMORI, NEUZA T.O.
SILVA, NATANAEL G. da
MATSUDA, MARGARETH M.N.
INTERNATIONAL NUCLEAR ATLANTIC CONFERENCE
Resumen
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.