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HPLC法测定阿托伐他汀钙及中间体L1的有关物质

任汉城, 江凡, 范青明, 袁镭, 钱志英, 赵海龙

任汉城, 江凡, 范青明, 袁镭, 钱志英, 赵海龙. HPLC法测定阿托伐他汀钙及中间体L1的有关物质[J]. 中国药科大学学报, 2014, 45(1): 70-75. DOI: 10.11665/j.issn.1000-5048.20140112
引用本文: 任汉城, 江凡, 范青明, 袁镭, 钱志英, 赵海龙. HPLC法测定阿托伐他汀钙及中间体L1的有关物质[J]. 中国药科大学学报, 2014, 45(1): 70-75. DOI: 10.11665/j.issn.1000-5048.20140112
REN Hancheng, JIANG Fan, FAN Qingming, YUAN Lei, QIAN Zhiying, ZHAO Hailong. Determination of the related substances of atorvastatin calcium and intermediate L1 by HPLC[J]. Journal of China Pharmaceutical University, 2014, 45(1): 70-75. DOI: 10.11665/j.issn.1000-5048.20140112
Citation: REN Hancheng, JIANG Fan, FAN Qingming, YUAN Lei, QIAN Zhiying, ZHAO Hailong. Determination of the related substances of atorvastatin calcium and intermediate L1 by HPLC[J]. Journal of China Pharmaceutical University, 2014, 45(1): 70-75. DOI: 10.11665/j.issn.1000-5048.20140112

HPLC法测定阿托伐他汀钙及中间体L1的有关物质

Determination of the related substances of atorvastatin calcium and intermediate L1 by HPLC

  • 摘要: 为了考察阿托伐他汀钙及其重要中间体L1的有关物质,合成了14个相关化合物,并建立了L1良好的HPLC分离条件(采用C18色谱柱,以水-乙腈-四氢呋喃-甲醇(36∶8.4∶29∶26.6)为流动相,检测波长246 nm)。结果显示中间体L1有4种潜在有关物质,阿托伐他汀钙有10种潜在有关物质。所建立的方法准确度高、重复性良好,适用于阿托伐他汀钙及中间体L1的有关物质检测。
    Abstract: To investigate the related substances of atorvastatin calcium(ATV-Ca)and it′s key intermediate L1, 14 related substances were synthesized, and an HPLC method was developed by using a C18 column, the mobile phase of H2O-CH3CN-THF-MeOH(36 ∶8. 4 ∶29 ∶26. 6), and the detection wavelength of 246 nm. There were 4 potential impurities in intermediate L1 and 10 potential impurities in ATV-Ca; The established methods were accurate and reproducible, which could be used for analysing the related substances in atorvastatin calcium and its key intermediate L1.
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    [2] Zhang MY, Sun GX. Content determination and related substances of 3 kinds of intermediates of atorvastatin calcium by HPLC[J].J China Pharm(中国药房),2013,24(1):83-85.
    [3] Zhang YP,Yang SL,Chen FE,et al.HPLC determination of related substances and enantiomeric purity of atorvastatin calcium[J].Chin J Pharm Anal(药物分析杂志),2010,30(12):2 311-2 313.
    [4] Indian Pharmacopoeia Commission.Indian Pharmacopoeia:volume 2[M].Ghaziabad:Indian Pharmacopoeia Commission,2010:849-851.
    [5] Gupta LK.Spectroscopic characterization and quantitative determination of atorvastatin calcium impurities by novel HPLC method[J].Spectrochim Acta A Mol Biomol Spectrosc,2012,97:495-501.
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出版历程
  • 刊出日期:  2014-02-24

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