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 |
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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) |
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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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