摘要
目的建立高效液相色谱法测定盐酸伊伐布雷定片含量的方法。方法采用Thermo ODS Hypersil色谱柱(4.6 mm×250 mm,5μm),流动相为0.5%甲酸溶液(用氨水调节pH值至6.5)-乙腈(68∶32),流速为1.0 mL.min-1,检测波长为286 nm。结果伊伐布雷定在119.98～279.95μg.mL-1的浓度范围内线性关系良好(r=0.999 9),平均回收率为99.92%,RSD为0.09%。结论本方法简便、快速、准确,可用于盐酸伊伐布雷定片的质量控制。
Objective To establish an HPLC method for the determination of Ivabradine Hydrochloride Tablets. Methods Thermo ODS Hypersil column（4.6 mm ×250mm,5μm） was adopted with 0.5% formic acid（ adjusted pH 6.5 by ammonia） - acetonitrile （ 68：32 ） as mobile phase, the flow rate was 1.0 mL·mim^-1 and the detection wavelength was 286 nm. Results The ivabradine showed a good linear relationship within the range of 119.98 -279.95μg·mL^-1 （ r = 0. 999 9 }, the average recovery was 99.92% and the RSD was 0.09%. Conclusion The method was convenient, rapid and accurate, and it can be used for the quality control of Ivabradine Hydrochloride Tablets.
出处
《齐鲁药事》
2012年第5期275-276,共2页
qilu pharmaceutical affairs
