摘要
目的：建立高效液相色谱测定阿比特龙原料药（乙酸阿比特龙酯）有关物质的方法,对乙酸阿比特龙酯原料药中具体杂质做一个定量的控制。方法：采用Luna C18色谱柱（250 mm＊4.6 mm,5μm）,流动相为甲醇-乙腈-水梯度洗脱,运行时间为60 min,检测波长220 nm,柱温40℃,流速1 m L/min。结果：乙酸阿比特龙酯与有关物质分离度良好,空白溶剂不干扰乙酸阿比特龙酯及其有关物质的检出;杂质A、杂质B、杂质C、杂质D、杂质E、杂质F分别在0.413～14.45μg·m L-1（r=0.9996）,0.420～14.71μg·m L-1（r=0.9997）,0.398～13.98μg·m L-1（r=0.9996）,0.450～15.74μg·m L-1（r=0.9999）,0.394～13.79μg·m L-1（r=0.9995）,0.387～13.54μg·m L-1（r=0.9998）范围内峰面积呈良好的线性关系;平均加样回收率（n=9）分别为：98.14%,99.34%,99.65%,100.27%,86.21%,97.64%,RSD分别为2.91%,2.59%,1.99%,1.69%,0.91%,3.68%（n=9）。最低检测限分别为：0.04、0.09、0.03、0.07、0.02、0.12μg·m L-1。结论：本方法灵敏度高,操作简便准确,重复性好,适用于乙酸阿比特龙酯有关物质检查。
Objective： To establish an HPLC method for the determination of related substances of Abiraterone acetate,make an quantitative control for the impurities of Abiraterone acetate. Methods： Luna C18 column（250 mm＊4.6 mm, 5 μm）, the mobile phase was methanol-acetonitrile-water eluted gradiently at the rate of 1.0 m L·min-1. The rnning time was 60 min, the detection wavelengths was220 nm, and the column temperature was 40 ℃. Results： The linear ranges were 0.413 ～14.45 μg·m L-1（r=0.9996）for impurity A,0.420～14.71 μg·m L-1（r=0.9997）for impurity B, 0.398～13.98 μg·m L-1（r=0.9996）for impurity C, 0.450～15.74 μg·m L-1（r=0.9999）for impurity D, 0.394～13.79 μg·m L-1（r=0.9995）for impurity E, 0.387～13.54 μg·m L-1（r=0.9998）for impurity F, respectively.The average recoveries（n=9） of the six components were 98.14%, 99.34%, 99.65%, 100.27%, 86.21% and 97.64%,with RSDs of 2.91%,2.59%, 1.99%, 1.69%, 0.91% and 3.68%（n=9）, respectively.The detection limits was 0.04, 0.09, 0.03, 0.07, 0.02, 0.12 μg·m L-1.Conclusion： This method was accurate, rapid, sensitive with high repeatability,which is more suitable for the determination of related substances of Abiraterone acetate.
出处
《现代生物医学进展》
CAS
2015年第28期5418-5423,共6页
Progress in Modern Biomedicine
基金
四川省科技支撑计划项目(2013SZ0084)
