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建立了[18F]-FDG注射液中杂质2-氯-2-脱氧-D葡萄糖(ClDG)含量的HPLC-MS测定方法。色谱柱为Alltima Amino 100A 5μ柱(250×4.6 mm),流动相为5 mmol/L乙酸铵-乙腈(10:90),柱温:35℃;流速:1 mL/min,进样量20μL。ClDG浓度在0.01～0.15 mg/mL范围内与峰面积有良好的线性关系,检出限为0.003 mg/mL,定量限为0.01 mg/mL。首次采用液质联用法检测[18F]-FDG注射液中杂质ClDG含量。
An HPLC-MS method for determination of impurity 2-chloro-2-deoxy-D-glucose (ClDG) in [18F] -FDG injection was established. The column was Alltima Amino 100A 5μ column (250 × 4.6 mm), the mobile phase was 5 mmol / L ammonium acetate-acetonitrile (10:90), the column temperature was 35 ℃, the flow rate was 1 mL / min and the injection volume was 20 μL. ClDG concentration in the range of 0.01 ~ 0.15 mg / mL and peak area has a good linear relationship with a detection limit of 0.003 mg / mL, the limit of quantification of 0.01 mg / mL. The first time using liquid chromatography-mass spectrometry [18F] -FDG injection of impurity ClDG content.