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 ��, and oriented synthesis and preparative liquid chromatography were used to prepare impurity ��. 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.
ZHANG Jing-Xia-,
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XU Ming-Qin- etc
.Structure Confirm of Impurities of Cefatrizine Propylene Glycolate[J] Chinese Pharmaceutical Journal, 2014,V49(23): 2112-2119
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[1]
SHUN D M, GAO Y Q, LIU F X. Determination of related substances in cefatrizine propylene glycolate by HPLC. Qilu Pharm Aff (��³ҩ��),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.
2014, Vol. 49 