| 超高效液相色谱串联质谱法分析磺苄西林钠原料中的杂质 |
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| 引用本文： | 马晓宁,冯芳. 超高效液相色谱串联质谱法分析磺苄西林钠原料中的杂质[J]. 中南药学, 2011, 9(4): 258-261. DOI: 10.3969/j.issn.1672-2981.2011.04.006 |
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| 作者姓名： | 马晓宁 冯芳 |
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| 作者单位： | 中国药科大学,南京,210009 |
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| 摘 要： | 目的建立超高效液相色谱串联质谱法分析磺苄西林钠原料中的杂质,并初步确定杂质的结构。方法采用Acquity UPLC BEH C18色谱柱,以10 mmol.L-1乙酸铵溶液-甲醇(90∶10)为流动相,以电喷雾电离源负离子模式进行质谱数据采集。结果获得磺苄西林和磺苄西林杂质的色谱图以及液相色谱图对应的质谱图,对谱图进行分析归纳,推测磺苄西林样品中2个未知杂质的结构分别为磺苄西林噻唑酸和磺苄西林噻唑酸甲酯化产物。结论本方法快速、灵敏、专属性高,对磺苄西林钠的生产和质量控制具有指导意义。
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| 关 键 词： | 超高效液相色谱串联质谱 磺苄西林 杂质 |
Determination of unknown impurities in sulbenicillin sodium by liquid chromatogram-mass spectrometry |
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| MA Xiao-ning,FENG Fang. Determination of unknown impurities in sulbenicillin sodium by liquid chromatogram-mass spectrometry[J]. Central South Pharmacy, 2011, 9(4): 258-261. DOI: 10.3969/j.issn.1672-2981.2011.04.006 |
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| Authors: | MA Xiao-ning FENG Fang |
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| Affiliation: | MA Xiao-ning,FENG Fang(China Pharmaceutical University,Nanjing 210009) |
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| Abstract: | Objective To analyze the unknown impurities in sulbenicillin sodium with ultra performance liquid chromatogram-mass spectrometry,and the structure of the unknown impurities was confirmed.Methods Acquity UPLC BEH C18 column（2.1 mm×50 mm,1.7 μm） with the mobile phases of methanol-10 mmol·L-1 ammonium acetate solution（10∶90）was used.Electrospay ionization source was applied and the mass data about MS were collected.Results The mass spectrum of the sulbenicillin sodium and its unknown impurities were determined.Two unknown impurities were identified as sulbenicilloic acid and the methylester of sulbenicilloic acid.Conclusion The method is rapid,sensitive,and specific.It can be used in the production and quality control of sulbenicillin sodium. |
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| Keywords: | UPLC-MS-MS sulbenicillin sodium impurity |
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