Structure Confirm of Impurities of Cefatrizine Propylene Glycolate

ZHANG Jing-xia,, XU Ming-qin,, CHEN Lin,, ZHANG Chun-ran,, WANG Yu-chi,, LI Zhe-yu,, TANG Ke-hui,*

Chinese Pharmaceutical Journal ›› 2014, Vol. 49 ›› Issue (23) : 2112-2119.

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Chinese Pharmaceutical Journal ›› 2014, Vol. 49 ›› Issue (23) : 2112-2119. DOI: 10.11669/cpj.2014.23.013
Original article

Structure Confirm of Impurities of Cefatrizine Propylene Glycolate

  • ZHANG Jing-xia1,2, XU Ming-qin1,2, CHEN Lin1,2, ZHANG Chun-ran1,2, WANG Yu-chi1,2, LI Zhe-yu1,2, TANG Ke-hui1,2*
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Abstract

OBJECTIVE To confirm the structures of the impurities of cefatrizine propylene glycolate. METHODS HPLC was employed to do a preliminary qualitative analysis of the related substances, preparative liquid chromatography was used to prepare impurity Ⅰ, and oriented synthesis and preparative liquid chromatography were used to prepare impurity Ⅱ. Then, UV, IR, MS and NMR and other analytical tools were used to comprehensively analyze the structures of the impurities. RESULTS Impurity I was confirmed as 4-hydroxyphenylglycine, and impurity II was confirmed as epimeride of cefatrizine. CONCLUSION This study of impurities has important significance for the quality control of cefatrizine propylene glycolate.

Key words

cefatrizine propylene glycolate / impurity / 4-hydroxyphenylglycine / epimeride / structure confirmation

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ZHANG Jing-xia,, XU Ming-qin,, CHEN Lin,, ZHANG Chun-ran,, WANG Yu-chi,, LI Zhe-yu,, TANG Ke-hui,*. Structure Confirm of Impurities of Cefatrizine Propylene Glycolate[J]. Chinese Pharmaceutical Journal, 2014, 49(23): 2112-2119 https://doi.org/10.11669/cpj.2014.23.013

References

[1] SHUN D M, GAO Y Q, LIU F X. Determination of related substances in cefatrizine propylene glycolate by HPLC. Qilu Pharm Aff (齐鲁药事),2008,27(8):467-480.[2] European Pharmacopoeia 7.0. Strasbourg: European Directorate for the Quality of Medicines, 2010: 1607-1608.[3] The British Pharmacopoeia Commission. The British Pharmacopoeia 2009. London: the Stationary Office, 2009:1121-1124.[4] Bristol-Myers Company. Crystalline cephalosporin derivative:United States, 3970651.1976-7-20.
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