GC 法测定丙酮酸乙酯注射液中EP 的含量

目的:建立测定丙酮酸乙酯的含量测定方法。方法:采用气相色谱法,以环戊酮为内标物。色谱柱为VARIAN CP7502(25 m×0.25 mm×0.25μm),柱温115℃,进样口温度210℃,FID检测器温度210℃,氮气(载气)流量为30 ml.min-1;氢气(燃气)流量为40 ml.min-1;空气(助燃气)流量为400 ml.min-1,分流比1:100。结果:EP进样浓度在0.50035 mg.ml-1～9.0063 mg.ml-1范围内与峰面积积分呈良好的线性关系(r2=0.9996),平均加样回收率为99.76%,RSD为0.46%。结论:本方法简便、快速、准确、重复性好,可用于丙酮酸乙酯注射液的质量控制。

Determination of EP in Ethyl Pyruvate Injection by Gas Chromatography

Objective: To develop a content determination method for the Determination of EP in ethyl pyruvate injection.Methods: The method of GC was applied to determine the content of EP.FID detector was used with cyclopentanone as internal standard for sample injection.The separation was performed on a VARIAN CP 7502 capillary column(25 m×0.25 mm×0.25 υm).The column temperature was 115 ℃;the injector temperature was 210 ℃;the FID temperature was 210 ℃.The flow rates were 30 ml·min-1 for carrier gas(N2),40 ml·min-1 for fuel gas(H2) and 400 ml·min-1 for assistant fuel gas(air) detector Split injection with a split ratio of 1:100 was used.Results: The calibration curve was linear within the concentration range of 0.50035 mg·ml-1～9.0063 mg·ml-1,r2 = 0.9996,the average recovery rate was 99.76 %,RSD was 0.46 %.Conclusion: The method is simple,rapid and accurate,with good reproducibility.It can be used for quality control of ethyl pyruvate injection.