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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×4mm,5μm)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0.02μg·mL-1(S/N≥10),检测限为0.004μg·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 a method for the determination of phosphate in injection fusion protein. Methods: The mobile phase was 30 mmol·L-1 KOH with flow rate of 1 mL · min-1 using AG-11HC guard column and AS11-HC analytical column (250 mm × 4 mm, 5 μm) . Results: The correlation coefficient was 0.9999 (n = 6) and the limit of quantification was 0.02μg · mL-1 (S / N≥10) in the range of 1.0-100.0 μg · mL-1 with the detection limit of 0.004μg · mL-1 (S / N≥10); The recovery was 102.3% (n = 6). Conclusion: The method has high selectivity and good sensitivity, and the determination result is more accurate. It can be used for the determination of phosphate in injection.