目的：建立测定氟[18F ]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－C18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( N2)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，R2=0.9990，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[18F ]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.
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