高效液相-蒸发光散射法检测氟[^(18)F]脱氧葡糖注射液中2-氯-2-脱氧-D葡萄糖含量  

Content Determination of the Concentration of CLDG in [^(18)F]-FDG by HPLC-ELSD

作　　者：张强[1] 谢新民[1] 周崝[2] 

机构地区：[1]中国人民解放军广州军区广州总医院药剂科,广东广州510010 [2]中国人民解放军广州军区广州总医院正电子药物中心,广东广州510010

出　　处：《中国药业》2016年第12期69-71,共3页China Pharmaceuticals

基　　金：广东省医学科研基金项目;项目编号:A2014493

摘　　要：目的建立测定氟[^(18)F]脱氧葡糖注射液中2-氯-2-脱氧-D葡萄糖(CLDG)含量的高效液相-蒸发光散射(HPLC-ELSD)法。方法色谱柱为SB-C_(18)柱(150 mm×2.1 mm,3.5μm),流动相为甲醇-0.1%三氟乙酸(10∶90),流速为0.2 mL/min,进样量为10μL;Sedex 85型低温型蒸发光散射检测器,载气(N_2)压力为3.0 bar,检测池温度为40℃,gain值为10。结果 CLDG质量浓度在5.06~135.00μg/mL范围内与峰面积同时取对数后呈良好线性关系,R^2=0.999 0,检测限为2μg/mL,定量限为5.0μg/mL。结论该方法简便、快速,适用于氟[^(18)F]脱氧葡糖注射液生产中的常规质量控制。Objective To establish an HPLC- ELSD method to determine the concentration of CLDG in [18F]- FDG. Methods The C18 column was used and the mobile phase was methanol-0. 1%TFA（10：90） at a flow rate of 0.2 mL/min. The auto-injection volume was set to 10 μL. The pressure of nebulizing gas（N2） was 3.0 bar. The drift tube temperature was 40 ℃. The gain was 10. Results Excellent linearity（R2 =0. 999 0） was obtained over the range of 5.06- 135.00 μg/mL. The limit of detection was 2 μg/mL,and the quantification limit was 5.0 μg/mL. Conclusion This method simple, rapid,quantitative and sensitive detection of CLDG in [18F]- FDG thus making it amenable to routine quality assurance testing.

关 键 词：高效液相-蒸发光散射法 2-氯-2-脱氧-D葡萄糖 氟[18F]脱氧葡糖注射液 

分 类 号：R927.1[医药卫生—药学] R979.1