反相高效液相色谱法测定复方醋酸钠注射液中醋酸钠含量

Determination of Sodium Acetate in Compound Sodium Acetate Injection by RP-HPLC

目的建立测定复方醋酸钠注射液中醋酸钠含量的反相高效液相色谱法。方法采用ICsepIce-Coregel 87H3型色谱柱,流动相为0.005mol/L硫酸,流速为0.6mL/min,柱温60℃,检测波长210nm。结果醋酸钠质量浓度在1.0～3.0g/L范围内与峰面积线性关系较好,r=0.9999;平均加样回收率为100.18%,RSD=0.31%(n=6);精密度试验的RSD=0.15%(n=6);最低检测限为99.15ng。结论所用方法简单、灵敏、准确,可作为复方醋酸钠注射液中醋酸钠含量测定的方法。

Objective To develop an RP-HPLC method for the determination of sodium acetate in Compound Sodium Acetate Injection.Methods To adopt ICsep Ice-Coregel 87H3 as the chromatographic column,0.005 mol /L sulphuric acid as the mobile phase,the detective wavelength at 210 nm,the flow rate was 0.6 mL /min and the temperature was 60 ℃.Results The linear concentration range of sodium acetate was 1.0-3.0 g /L（r = 0.999 9）.The average recovery rate was 100.18%（RSD = 0.31%）.The precision RSD was 0.15%.The lowest detection limitation was 99.15 ng.Conclusion The method is simple,sensitive and accurate,which can meet the requirements for determination of sodium acetate in Compound Sodium Acetate Injection.