离子色谱法测定注射用融合蛋白中磷酸根的含量

目的: 建立注射用融合蛋白中磷酸根的含量测定方法。方法: 采用AG-11HC保护柱和AS11-HC分析柱(250 mm×4 mm，5 μm)以30 mmol·L^-1KOH为流动相，流速1 mL·min^-1，电导检测器，柱温为30℃。结果: 磷酸根在1.0~100.0 ug·mL^-1浓度范围内线性关系良好，相关系数为0.9999(n=6)；定量限为0.02 μg·mL^-1(S/N≥10)，检测限为0.004 μg·mL^-1(S/N≥10)；回收率为102.3%(n=6)。结论: 本方法选择性高，灵敏度好，测定结果较为准确，可用于注射剂中磷酸盐的测定。

Objective: To establish an ion chromatographic(IC) method for the determination of phosphate in fusion protein injection. Methods: The AG-11HC anion guard column and the AS11-HC anion analytical column(250 mm×4mm,5 μm)were employed to separate and determine phosphate with 30 mmol·L^-1 KOH as the mobile phase.The flow was 1.0 mL·min^-1,and the conductivity detector was used,the column temperature was 30℃. Results: A good linear relationship was established within the concentration of 1.0 - 100.0 μg·mL^-1,the coefficient correlation was 0.99998(n=6),with the quantitation limit (S/N=10) of 0.02 μg·mL^-1 (S/N≥10),and the detection limit of 0.004 μg·mL^-1 (S/N≥10),the recovery was 102.3%(n=6).Conclusion: The proposed method shows high selectivity,sensitivity and accurate results.It can be employed for the determination of phosphate in injections.

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