Detection method of cefuroxime sodium related substances for injection

The invention discloses a method for detecting related substances of cefuroxime sodium for injection, and belongs to the technical field of medical analysis. According to the method, a sodium acetate buffer solution after ultrasonic treatment is used as a mobile phase A, acetonitrile after ultrasoni...

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Bibliographische Detailangaben
Hauptverfasser: MA LI, ZHAO LINLIN, NAKADATSU
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention discloses a method for detecting related substances of cefuroxime sodium for injection, and belongs to the technical field of medical analysis. According to the method, a sodium acetate buffer solution after ultrasonic treatment is used as a mobile phase A, acetonitrile after ultrasonic treatment is used as a mobile phase B, high performance liquid chromatography (HPLC) detection is carried out, and octadecylsilane chemically bonded silica is used as a filling agent of a chromatographic column; cefuroxime sodium for injection is diluted with purified water to prepare a positive sample 1, and a mobile phase A-mobile phase B solution with the volume ratio of 1: 1 is diluted to prepare a positive sample 2. The cefuroxime sodium micromolecule organic impurities and polymers for injection can be detected under the same chromatographic condition, and the method is high in sensitivity and good in specificity. 本发明公开了一种注射用头孢呋辛钠有关物质的检测方法,属于医药分析技术领域。本发明采用超声后的醋酸钠缓冲溶液作为流动相A,超声后的乙腈为流动相B进行高效液相色谱(HPLC)检测,色谱柱以十八