Development of ICP-OES Method for Determination Copper Tetramibi Tetrafluoroborate Active Substance Content in a Kit for Radiopharmaceutical Preparation.
The aim of this study was to develop a fast, quantitative method for the determination of copper tetramibi tetrafluoroborate active substance content in the POLATOM’s PoltechMIBI kit before radiolabeling, using inductively coupled plasma optical emission spectrometry (ICP-OES). Copper tetramibi is a key complex that after radiolabeling with sodium pertechnetate [99mTc], forms technetium [99mTc] sestamibi used primarily for detection of myocardial perfusion abnormalities. Indirect method that determines Cu content was developed and validated according to ICH guidelines and European Pharmacopoeia validation requirements, showing good linearity, accuracy, precision and intermediate precision between two different ICP-OES systems, making it suitable and adequate for routine analysis.
Authors
- Magdalena Fiszer (ORCID: https://orcid.org/0000-0002-7406-0829)
- Łukasz Sochaczewski (ORCID: https://orcid.org/0000-0002-9795-6759)
- Anna Filiks (ORCID: https://orcid.org/0000-0001-9981-1521)
Institutions
- National Centre for Nuclear Research (PL)
Publication Details
- Journal
- Acta Poloniae Pharmaceutica - Drug Research
- Published
- 2025-04-09
- DOI
- https://doi.org/10.32383/appdr/201435
- Primary Topic
- Analytical chemistry methods development
- Type
- article
- Field-Weighted Citation Impact
- 0.00