GC法测定丙酮酸乙酯注射液中EP的含量

Determination of EP in Ethyl Pyruvate Injection by Gas Chromatography

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。

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,r^2 = 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.