| HPLC法测定乙酰胺注射液的有关物质 |
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| 引用本文： | 闫敏,仇丽红,王飞,李静,刘云.HPLC法测定乙酰胺注射液的有关物质[J].齐鲁药事,2012,31(12):708-709. |
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| 作者姓名： | 闫敏 仇丽红 王飞 李静 刘云 |
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| 作者单位： | 山东新华制药股份有限公司,山东 淄博,255005 |
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| 摘 要： | 目的建立高效液相色谱法测定乙酰胺注射液有关物质的方法。方法采用phenomenex Gemini C18(4.6 mm×250 mm,5μm)色谱柱,流动相为0.05 mol.L-1辛烷磺酸钠(用磷酸调节pH值至3.0)-乙腈=95∶5,检测波长:210nm,流速:1.0 mL.min-1。结果乙酰胺与杂质能完全分离;最小检出量为2.0 ng。结论本方法操作简便、灵敏准确,专属性强,可用于乙酰胺注射液有关物质的检测。
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| 关 键 词： | 高效液相色谱法 乙酰胺注射液 有关物质 |
Determination of the related substances in Acetamide Injection by HPLC |
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| YAN Min
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QIU Li-hong
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WANG Fei
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LI Jing
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LIU Yun.Determination of the related substances in Acetamide Injection by HPLC[J].qilu pharmaceutical affairs,2012,31(12):708-709. |
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| Authors: | YAN Min QIU Li-hong WANG Fei LI Jing LIU Yun |
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| Institution: | (Shandong Xinhua Pharmaceutical Co.,Ltd.,Zibo 255005,China) |
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| Abstract: | Objective To establish an HPLC method for the determination of the related substances in Acetamide Injection.Methods The phenomenex Gemini C18 column(4.6 mm×250 mm,5 μm)was adopted.The mobile phase was 0.05 mol·L-1 Sodium 1-octanesulfonate solution(adjusted pH to 3.0 with phosphate)-acetonitrile(95∶5).The detection wavelength was 210 nm and the flow rate was 1.0 mL·min-1.Results Under the described chromatographic condition,acetamide was completely separated from its impurities and the minimum detectable amount was 2.0 ng.Conclusion The method was simple,sensitive,accurate and specific.It can be used for the quality control of Acetamide Injection. |
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| Keywords: | HPLC Acetamide Injection Related substances |
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