Method for detecting related substances of ceftriaxone sodium, ceftriaxone sodium dimer and preparation method and application of ceftriaxone sodium dimer

The invention discloses a ceftriaxone sodium related substance detection method, a ceftriaxone sodium dimer and a preparation method and application of the ceftriaxone sodium dimer. The method for detecting the related substances of the ceftriaxone sodium, provided by the invention, comprises the fo...

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Hauptverfasser: LIU SHAOQUN, CHEN LONG, LIU JUNJUN, YAO MENGXIA, ZHANG LU, GONG DANFENG, CHEN CHENG
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention discloses a ceftriaxone sodium related substance detection method, a ceftriaxone sodium dimer and a preparation method and application of the ceftriaxone sodium dimer. The method for detecting the related substances of the ceftriaxone sodium, provided by the invention, comprises the following steps: detecting a ceftriaxone sodium product to be detected by adopting a high performance liquid chromatography, and the chromatographic conditions are as follows: a chromatographic column is a C18 chromatographic column; the mobile phase A is a formic acid-ammonium formate buffer solution; the mobile phase B is a mixed solution of a formic acid-ammonium formate buffer solution and acetonitrile; wherein the volume ratio of the formic acid-ammonium formate buffer solution to the acetonitrile is 3/7-1/9; the elution procedure of the high performance liquid chromatography is gradient elution. According to the detection method, separation and identification of the ceftriaxone sodium dimer impurity in the ceft