GC法测定正电子类放射性药物制剂中有机溶剂残留量  

GC Determination of Residual Solvents in PET Radiopharmaceutical Injection

作　　者：武仙英[1] 贾娟娟[2] 乔洪文[3] 邓艾芳[1] 乔晋萍[1] 朱霖[1,4] 钟建国[2] 

机构地区：[1]北京师范大学化学学院,北京100875 [2]中国食品药品检定研究院,北京100050 [3]首都医科大学宣武医院,北京100053 [4]北京脑重大疾病研究院帕金森病研究所,北京100053

出　　处：《解放军药学学报》2014年第4期303-305,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：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[18F]AV-133和[18F]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 radiopharmaceutical injection. Methods The residual solvents in PET radiopharmaceutical injection were separated by DBFFAP 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 programmed as follows： maintained at 40 ℃ for 5 min,raised to 200 ℃ at the rate of 40 ℃·min- 1,and maintained again for5 min. Hand injection was used in a splitless model. Results The linear range of acetonitrile and dimethylsulfoxide was0. 008%-0. 080%（ g·g- 1）（ r =0.998） and0.10%-1.00%（ g·g- 1）（ r =0.9964）,respectively. The average recovery 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 [18F]AV-133 and [18F]AV-45.

关 键 词：正电子类放射性药物注射剂 乙腈 二甲亚砜 GC 

分 类 号：R927.2[医药卫生—药学]