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建立HPLC测定甲磺酸托烷司琼的有关物质。采用C18色谱柱,以甲醇-水-乙腈-三乙胺(565:40:35:0.3,V/V/V/V)为流动相A,以甲醇-水-乙腈-三乙胺(800:100;100:0.24,V/V/V/V)为流动相B,梯度洗脱检查有关物质;检测波长为284nm。甲磺酸托烷司琼检出限为0.24ng,主成分与其有关物质能完全分离。方法简便、准确、专属性好,可用于甲磺酸托烷司琼有关物质的测定。
To establish HPLC determination of related substances of tropisetron mesylate. The mobile phase A was obtained on a C18 column with methanol-water-acetonitrile-triethylamine (800: 1) using methanol- water- acetonitrile- triethylamine at 565:40:35:0.3 V / V / 100; 100: 0.24, V / V / V / V) as the mobile phase B, gradient elution related substances; detection wavelength of 284nm. The limit of detection of tropisetron methanesulfonate was 0.24ng. The main components and their related substances could be completely separated. The method is simple, accurate and specific and can be used for the determination of related substances of tropisetron mesylate.