【摘要】 目的建立富马酸比索洛尔片的含量及有关物质的测定方法。方法采用C18色谱柱,流动相为甲醇-pH5.0醋酸钠溶液(60∶40为含量测定的流动相,50∶50为有关物质检测的流动相);检测波长271nm;流速1.0ml·ml-1。结果辅料对主药测定无干扰,在选定的色谱条件下,富马酸比索洛尔与有关物质分离很好,在浓度0·2~1·0mg·ml-1范围内线性关系良好,有关物质含量为0.81%,回收率为99.93%,RSD=0.36%。结论所用方法简单、准确、经济、专属性强,可用于富马酸比索洛尔片中有关物质及含量的测定。更多还原

【Abstract】 OBJECTIVE An RP-HPLC method for the determination of Bisoprolol fumarate and the related substances in tablets was developed.METHODS The sample was carried out on a C18 column using a mobile phase of methanol-sodium acetate buffer (pH5.0) with 60∶40 for determining the content and with 50∶50 for determining the related substances.The flow rate was 1.0 ml·ml~-1 and the detective wavelength was set at 271 nm.RESULTS The method was validated and the stability tests under various conditions were performed.The standard curve was linear in the range of 0.2-1.0 mg·ml~-1 with the correlation coefficient of 0.9999.The average recovery was 99.93% with RSD of 0.36%.CONCLUSION The method is simple,accurate, specific,and it could be used for quality control of Bisoprolol fumarate tablets.更多还原