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

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    • 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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    • References (5)
  • [1]
    Xia ZJ,Ma YQ,Lin S,et al.Total synthesis of(3S,5R)-epimers of atorvastatin calcium[J].Guangdong Chem Ind(广东化工杂志),2012,10(39):29-30.
    [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.
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    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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