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目的建立气相色谱(GC)法测定正电子类放射性药物注射剂中有机溶剂残留量的方法。方法色谱柱为HP-INNOWAX毛细管柱(30 m×0.53 mm,1μm),FID检测器,程序升温,进样口温度200℃,检测器温度270℃,载气为氮气。结果采用顶空内标法,乙腈、丙酮和乙醇能较好分离,线性关系良好(r=0.9999、0.9973、0.9988),平均回收率为99.8%、101.0%、97.5%,RSD值<5%。所测样品中有机溶剂残留符合规定,与顶空外标法结果基本一致。结论该方法简便快速,灵敏度高,准确可靠,适用于18F-FDG中残留有机溶剂测定。
Objective To establish a method for the determination of residual organic solvents in positron -c-type radiopharmaceutical injection by gas chromatography (GC). Methods The column was HP-INNOWAX capillary column (30 m × 0.53 mm, 1 μm) with FID detector. The program temperature was raised. The inlet temperature was 200 ℃ and the detector temperature was 270 ℃. The carrier gas was nitrogen. Results The headspace internal standard method was used. Acetonitrile, acetone and ethanol could be separated well. The linearity was good (r = 0.9999, 0.9973, 0.9988). The average recoveries were 99.8%, 101.0% and 97.5% with RSD values less than 5%. The measured organic solvent residues in the sample in line with the provisions of the external standard method with the headspace basically the same. Conclusion The method is simple, rapid, sensitive, accurate and reliable and suitable for the determination of residual organic solvents in 18F-FDG.