摘要
目的:建立地高辛片溶出度的高效液相色谱分析方法。方法:以十八烷基硅烷键合硅胶为色谱柱;乙腈-水(32∶68)为流动相;流量1.0 mL·min-1;柱温30℃;检测波长230 nm。结果:地高辛在0.1008～4.032μg·mL-1的范围内呈现良好的线性关系(r=0.999 9);平均回收率为99.4%,RSD为0.7%(n=9)。结论:本方法简便、快速、专属性强,重现性好,可作为该制剂的溶出度测定方法。
Objective：To establish an HPLC method for the assay of Digoxin Tablets. Methods： The C18 column was used, the mobile phase was Acetonitrile-water （32： 68） , the flow rate was 1.0 L min-1, the detection wavelength was set at 230nm. Results：The lin- ear range of digoxin was 0. 10084. 032 μg mL-1 （ r = 0. 999 9）. The average recovey （ n = 9） was 99.4% （ RSD = O. 7% ）. Con- clusions ： The method is proved to be rapid, accurate and convenient, and provided a reliable way for assaying of dissolution of Digoxin Tablets.
出处
《中国药品标准》
CAS
2012年第3期214-216,共3页
Drug Standards of China
