论文部分内容阅读
目的：建立GC法测定正电子类放射性药物注射剂中有机溶剂残留量。方法色谱柱为DB-FFAP石英毛细管柱（30 m ×0.32 mm，0.5μm），FID检测器，载气为氮气。进样口温度200℃；检测器温度250℃；程序升温：初始温度40℃，保持5 min，以40℃·min-1升温至200℃，保持5 min。手动进样，不分流模式。结果乙腈在0.008%~0.080%（g·g-1）范围内线性关系良好（ r ＝0.9981），[18F]AV-133和[18F]AV-45制剂的平均加样回收率分别为94.26%和93.74%，RSD为3.27%和5.23%（ n ＝9）；二甲亚砜在0.10%~1.00%（g·g-1）范围内线性关系良好（ r ＝0.9964），[18F]AV-133和[18F]AV-45制剂的平均加样回收率分别为96.10%和100.75%，RSD为5.17%和6.52%（ n ＝9）。结论该法简单、灵敏、准确，重复性好，适用于[18 F]AV-133和[18 F]AV-45制剂有机溶剂残留量的检测。“,”Objective To establish a method of GC for the determination of residual organic solvents in PET ra-diopharmaceutical injection. Methods The residual solvents in PET radiopharmaceutical injection were separated by DB-FFAP capillary column(30 m × 0. 32 mm,0. 5 μm)and analyzed with an FID detector. The carried gas was nitrogen. The injector and detector temperatures were controlled at 200 ℃ and 250 ℃,respectively. The temperature was pro-grammed as follows:maintained at 40℃ for 5 min,raised to 200℃ at the rate of 40℃·min-1 ,and maintained again for 5 min. Hand injection was used in a splitless model. Results The linear range of acetonitrile and dimethylsulfoxide was 0. 008% -0. 080%(g·g-1)( r =0. 998)and 0. 10% -1. 00%(g·g-1)( r =0. 9964),respectively. The average recov-ery of acetonitrile was 94. 26%(RSD=3. 27%)and 93. 74%(RSD=5. 23%)for[18F]AV-133 and[18F]AV-45,while that of dimethylsulfoxide was 96. 10%(RSD=5. 17%)and 100. 75%(RSD=6. 52%)for[18F]AV-133 and[18F]AV-45,respectively. Conclusion This method is simple,accurate and sensitive with good reproducibility. It can be used for the determination of the residual organic solvents in[18 F]AV-133 and[18 F]AV-45.