Method for detecting fumaric acid impurities related to chlorpheniramine maleate and preparation thereof

The invention relates to a method for detecting fumaric acid impurities related to chlorpheniramine maleate and a preparation thereof, which adopts high performance liquid chromatography, and the chromatographic conditions are as follows: a chromatographic column is a core-shell chromatographic colu...

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Hauptverfasser: YOU QIUXIA, WU MENG, LIAN MENGYUAN, ZHOU PU, LU QINWEI, ZHOU ZHE, LIU LING, YE YINGJIAN, HOU LI, YANG FEI, JIANG PEI, QIAO XIAOFANG, ZHANG HONGTAI, ZHANG JUNLING, ZHOU HONGJIAN, MA HONGLI, LI JUNXIA, ZHAO MINGYANG, GUO QI, FENG HUIPING, WANG MEILING, LIU NANA
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention relates to a method for detecting fumaric acid impurities related to chlorpheniramine maleate and a preparation thereof, which adopts high performance liquid chromatography, and the chromatographic conditions are as follows: a chromatographic column is a core-shell chromatographic column; the column temperature is 25-35 DEG C; a mobile phase A is a phosphoric acid aqueous solution; a mobile phase B is acetonitrile; the detection wavelength is 223 to 227 nm, and the flow velocity is 0.5 to 0.7 ml/min; the method comprises the following specific detection steps: step 1) preparing a system applicability solution and a test solution; 2) based on the chromatographic conditions, performing sample injection detection by adopting a high performance liquid chromatograph with an ultraviolet detector to obtain a system applicability solution spectrogram and a test solution spectrogram; and 3) carrying out qualitative and quantitative analysis on fumaric acid impurities according to the obtained system appl