研究目的
To investigate the sorption of ionic 68Ga species on reversed-phase columns and its impact on the determination of radiochemical purity in 68Ga radiopharmaceuticals.
研究成果
The study concludes that ionic 68Ga species can be significantly sorbed on C18 reversed-phase columns, leading to underestimation of free 68Ga in HPLC analyses, especially at higher pH. TLC is recommended for more reliable determination of radiochemical purity in 68Ga radiopharmaceuticals.
研究不足
The study is limited to 68Ga radiopharmaceuticals and may not generalize to other radionuclides. The sorption effect varies with pH and buffer type, and instrumental errors could influence results. Further research is needed to understand the chemical mechanisms behind the sorption.
1：Experimental Design and Method Selection:
The study compared TLC and HPLC methods for analyzing 68Ga radiopharmaceuticals, focusing on sorption effects on C18 reversed-phase columns. Various chromatographic systems and conditions were used to assess radiochemical purity.
2：Sample Selection and Data Sources:
Samples included eluates from 68Ge/68Ga generators, purified 68Ga solutions, and model radiopharmaceuticals like [68Ga]Ga-DOTA-TATE and [68Ga]Ga-DOTA-PSMA. Buffers such as sodium acetate and HEPES were used to adjust pH.
3：List of Experimental Equipment and Materials:
Equipment included TLC scanners, HPLC systems, dose calibrators, radiometers, gamma counters, and C18 cartridges. Materials included iTLC-SG strips, various chemicals (e.g., TFA, acetonitrile), and chelators like NOTA and DOTA.
4：Experimental Procedures and Operational Workflow:
Procedures involved preparing samples at different pH levels, performing TLC and HPLC analyses, measuring activity recovery, and conducting dynamic sorption experiments with C18 cartridges. Data were collected on activity distribution and recovery rates.
5：Data Analysis Methods:
Data were analyzed using statistical methods to calculate recovery percentages and correlations between TLC and HPLC results. Regression analysis was applied to compare methods.
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Radiometric detector
fLumo
Berthold
Detecting radioactivity in HPLC eluate
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Gamma counter
2480 Wizard2
Perkin Elmer
Automatic counting of gamma radiation
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68Ge/68Ga generator
Based on TiO2 modified with 4% ZrO2
Cyclotron
Producing 68Ga radionuclide for radiopharmaceuticals
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TLC scanner
miniGITA
Raytest
Determining activity distribution along chromatographic strips
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HPLC system
Smartline
Knauer
Performing high-performance liquid chromatography analysis
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Dose calibrator
RIS-А1
Amplituda Scientific and Technical Center
Measuring absolute activity of 68Ga
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Dose calibrator
Atomlab 500
Biodex
Measuring absolute activity of 68Ga
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Radiometer
RFT 20046
Veb Robotron-Messelektronik
Measuring relative activity (counting rate) of samples
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Automated module
Modular-Lab PharmTracer
Eckert & Ziegler
Purifying and concentrating eluate, preparing radiopharmaceuticals
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Pipette
Eppendorf Reference 2
Eppendorf AG
Taking aliquots for reference samples
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C18 cartridge
CHROMAFIX C18-S
Macherey-Nagel
Dynamic sorption experiments to confirm HPLC effects
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HPLC column
Chromolith Performance
Merck
Chromatographic separation with reversed C18 phase
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HPLC column
Luna
Phenomenex Inc.
Chromatographic separation with reversed C18 phase
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HPLC column
ACE
Advanced Chromatography Technologies Ltd.
Chromatographic separation with reversed C18 phase
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Water purification system
Smart2Pure
TKA
Producing deionized water for experiments
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