RP-HPLC法测定注射用奥美拉唑钠中乙二胺四乙酸二钠的含量

Determination of disodium edetate in omeprazole sodium for injection by RP-HPLC

目的建立注射用奥美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 CLC-ODS（150 mm×4.6 mm,5μm）,流动相为乙腈：缓冲液（10%四丁基氢氧化铵溶液6 ml,加水稀释至200 ml,以磷酸调节pH值为6.5）：水（20：20：60）,检测波长为254 nm,流速为1.0 ml.min-1,进样量为20μl。结果乙二胺四乙酸二钠进样量在0.1~2.0μg范围内,线性关系良好（r=0.9999）,平均回收率为99.6%,RSD为1.96%（n=9）。结论本法简便、准确、灵敏度高,重复性好,可用于注射用奥美拉唑钠中乙二胺四乙酸二钠的含量测定。

Aim To determine disodium edetate in omeprazole sodium for injection.Methods The chromato-graphic column was Shim-Pack CLC-ODS（150 mm×4.6 mm,5 μm）,with acetonitrile：aqueous tetrabutylammonium phosphate buffer：water（20：20：60）as the mobile phase.The detection wavelength was 254 nm and the flow rate was 1.0 ml·min-1.The injection volume was 20 μl.Results The calibration curves of disodium edetate were linear in the range from 0.1 to 2.0 μg（r=0.9999）.The average recovery was 99.6%,with RSD of 1.96%（n=9）.Conclusion The method is simple and accurate,sensible and reproducible,which can be used for the quality control of determining disodium edetatein in omeprazole sodium for injection.