头孢哌酮钠中乙二胺四乙酸二钠的检查

Determination of disodium ethylenediamintetraacetate in the cefoperazone sodium by HPLC gradient

目的运用高效液相色谱法测定头孢哌酮钠原料药中乙二胺四乙酸二钠的含量。方法采用依利特ODS C18色谱柱(4.6 mm×250 mm,5μm);以pH 3.4醋酸盐缓冲液及乙腈为流动相,进行梯度洗脱;流速1.5 mL/min;检测波长254 nm;柱温40℃。结果 EDTA-2Na的浓度与峰面积在25.23～75.68μg/mL范围内呈良好的线性关系,回归方程为:Y=6.5401X+5.4383,r=0.9999;平均回收率97.7%,RSD为1.0%。结论该方法可行,对头孢哌酮钠的质量控制有一定的意义。

Objective To establish an HPLC gradient test method of EDTA-2Na in cefoperazone sodium material. Methods HPLC was performed on Elite ODS C18 column（4. 6 mm × 250 mm,5μm）at 40 ℃ with the mobile phase of acetonitrile and acetic acid pH 3.4 at a flow rate of 1.5 mL/min. And the ultraviolet detection wavelength was 254 nm. Results The linear range of sodium lactate was 250-750μ g/mL. Regression equation： Y=6.5401X＋5.4383 （ r=0.9999 ） ; The average recovery ratio was 97.7% （RSD=I.0%）. Conclusion The proposed method is suitable for determination of EDTA-2Na of cefoperazone sodium material.