文章摘要
吴青松 孙岩 卢金富 雷冬梅 赵闻迪 李孝红 张志斌.阿比特龙原料药有关物质方法学研究[J].,2015,15(28):5418-5423
阿比特龙原料药有关物质方法学研究
Relative Substances Test of Abiraterone by HPLC
  
DOI:
中文关键词: 乙酸阿比特龙酯  有关物质  高效液相色谱法
英文关键词: Abiraterone acetate  Related substances  HPLC
基金项目:四川省科技支撑计划项目(2013SZ0084)
作者单位
吴青松 孙岩 卢金富 雷冬梅 赵闻迪 李孝红 张志斌 西南交通大学生命科学与工程学院西南交通大学材料科学与工程学院 
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中文摘要:
      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, 5 滋m),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 mL/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0.413~14.45 ug·mL-1(r=0.9996),0.420~14.71 滋g· mL-1(r=0.9997),0.398~13.98 ug·mL-1(r=0.9996),0.450~15.74 ug·mL-1(r=0.9999),0.394~13.79 ug·mL-1(r=0.9995),0.387~ 13.54 ug·mL-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 、 0.12 滋g·mL-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。
英文摘要:
      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 um), the mobile phase was methanol-acetonitrile-water eluted gradiently at the rate of 1.0 mL·min-1. The rnning time was 60 min, the detection wavelengths was 220 nm, and the column temperature was 40 ℃ .Results:The linear ranges were 0.413~14.45ug·mL-1(r=0.9996)for impurity A, 0.420~14.71 滋g·mL-1(r=0.9997)for impurity B, 0.398~13.98 ug·mL-1(r=0.9996)for impurity C, 0.450~15.74 ug·mL-1(r=0.9999) for impurity D, 0.394~13.79 滋g·mL-1(r=0.9995)for impurity E, 0.387~13.54 ug·mL-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 ug·mL-1.Conclusion:
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