醋酸优力司特片有关物质检查方法的建立  

Study on Determination Method for Related Substances of Ulipristal Acetate Tablets

作　　者：彭贵子[1,2] 林生文 彭苗 陶艳 张瑾 许铄 黄和意 左联 

机构地区：[1]广州朗圣药业有限公司研发中心,广州510670 [2]中山大学药学院,广州510160 [3]广东省药品食品检验所,广州510160 [4]广州市玉岩中学,广州510530

出　　处：《中国药品标准》2016年第1期43-46,共4页Drug Standards of China

摘　　要：目的:建立醋酸优力司特片有关物质检查方法。方法:以碳十八烷基键合硅胶柱为填充剂,0.01 mol·L^(-1)磷酸二氢钾溶液-乙腈(35∶65)为流动相,流量为1.0 m L·min^(-1),检测波长为304 nm。结果:醋酸优利司特片主成分色谱峰与主要降解产物色谱峰能得到较好的分离,对特定杂质N-去甲基醋酸优力司特进行了控制。结论:所建方法能较好地控制该产品的有关物质。Objective： To establish a method for determining related substances of Ulipristal Acetate Tablets. Methods： HPLC was adopted and the separation was performed on a Cls column with a mixture of 0. 01 mol · L^-1 potassium dihydrogen phosphate and aceto- nitrile （35：65） as mobile phase. The flow rate was 1.0 mL · min^-1 and the detection wavelength was set at 304 nm. Results： The main peak of Ulipristal Acetate Tablets was well separated from degradation impurities. The main degradation impurity N-demethylulip- ristal acetate was identified and assayed. Conclusion： The newly established method can be used for quality control of Ulipristal Acetate Tablets.

关 键 词：醋酸优力司特片 N-去甲基醋酸优力司特 有关物质 降解产物 

分 类 号：R921.2[医药卫生—药学]