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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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  • 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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