Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Changjun Fan

Hongyu Chen

Min Sun

Xiangfeng Chen

Shuaihua Tian

A high performance liquid chromatography method used for dexrazoxane-related substances is provided, and in the method, a low-density bonding reversed-phase C18 chromatographic column resistant to pure water is employed; a gradient elution is carried out with mobile phase A and mobile phase B as eluents, the mobile phase A being a buffer, and the mobile phase B being an organic solvent; the volume percent of mobile phase A in eluents in a first stage of the gradient elution is not lower than 90%, and the duration of the first stage of the gradient elution ranges from 15&#x2dc;30 minutes. By means of the analytical method, dexrazoxane is effectively separated from main impurities, and the qualities of the active pharmaceutical ingredients of dexrazoxane and the preparations thereof could be better controlled.

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Nanjing, China

Changjun Fan