HPLC法测定注射用泮托拉唑钠中乙二胺四乙酸二钠的含量

目的: 建立注射用泮托拉唑钠中乙二胺四乙酸二钠的含量测定方法。 方法: 色谱柱为Shim-Pack VP-ODS(150 mm×4.6 mm,5 μm),流动相为乙腈(A)-0.025 mol·L^-1硫酸铵(用稀硫酸调节pH至3.0)(B),梯度洗脱(0~5 min,100%B;5~10 min,100%B→50%B;10~15 min,50%B;15~20 min,50%B→100%B),柱温为25 ℃,检测波长为254 nm,流速为1.0 mL·min^-1,进样量为20 μL。 结果: 乙二胺四乙酸二钠进样量在0.083~0.83 μg范围内线性关系良好(r=0.9999),平均回收率为99.9%(n=9)。 结论: 本法简便、准确,灵敏度高,重复性好,可用于注射用泮托拉唑钠中乙二胺四乙酸二钠的含量测定。

Objective: To determine the contents of disodium edetate in pantoprazole sodium for injection. Methods: The chromatographic column was Shim-Pack VP-ODS(150 mm×4.6 mm,5 μm);the mobile phase consisted of acetonitrile(A)-0.025 mol·L^-1 ammonium sulfate(adjusted to pH 3.0 with diluted sulfuric acid)(B),gradient elution (changed from 0-5 min with 100%B;5-10 min with 100%B→50%B;10-15 min with 50%B;15-20 min with 50%B→100%B),the column temperature was 25 ℃;the detection wavelength was 254 nm and the flow rate was 1.0 mL·min^-1,the amount of injection was 20 μL. Results: The calibration curve of disodium edetate was linear in the range of 0.083-0.83 μg(r=0.9999),the average recovery was 99.9%(n=9). Conclusions: The method is simple,accurate,sensible and reproducible,which can be used for the determination of disodium edetate in pantoprazole sodium for injection.