| 彭洁1 王钊1 李晓晔2 陈宏莉1 李穆琼2 廖鼐1 海春旭1△.GC 法测定丙酮酸乙酯注射液中EP 的含量[J].,2012,12(15):2822-2825 |
| 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 |
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| DOI： |
| 中文关键词: 气相色谱法 丙酮酸乙酯 含量测定 |
| 英文关键词: GC Ethyl pyruvate Content determination |
| 基金项目:长江学者，创新团队发展计划资助和十一五“重大新药创制”资助（2009ZXJ09002-021） |
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| 中文摘要: |
| 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×0.25 μm），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。 |
| 英文摘要: |
| 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 μm）.
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. |
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