RP-HPLC法测定阿齐沙坦的有关物质
投稿时间:2016-06-21  修订日期:2016-07-07  点此下载全文
引用本文:吴标,王娟,崔红晓,潘显道.RP-HPLC法测定阿齐沙坦的有关物质[J].医学研究杂志,2017,46(3):178-181
DOI: 10.11969/j.issn.1673-548X.2017.03.044
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作者单位E-mail
吴标 230088 合肥, 合肥久诺医药科技有限公司  
王娟 230088 合肥, 合肥久诺医药科技有限公司  
崔红晓 230088 合肥, 合肥久诺医药科技有限公司  
潘显道 100050 北京, 中国医学科学院/北京协和医学院 xdp@imm.ac.cn 
中文摘要:目的 建立用高效液相色谱法测定阿齐沙坦中有关物质方法。方法 采用Agilent C18柱(250mm×4.6mm,5μm),以乙腈∶水∶冰醋酸(57∶42∶1)为A相,以乙腈-水-冰醋酸(90∶9∶1)为B相,梯度洗脱,流速为0.8ml/min,检测波长为250nm。结果 在选定色谱条件下,阿齐沙坦与各杂质之间分离良好,杂质A、杂质B、杂质C浓度分别在0.122~8.114mg/L(r=0.9999)、0.121~8.064mg/L(r=0.9998)、0.122~8.156mg/L(r=0.9993)范围内与峰面积呈良好的线性关系。上述杂质的平均回收率分别为97.50%、96.82%、96.09%,RSD分别为5.10%、3.02%、2.99%(n=9)。结论 本方法专属性好,可用于测定阿齐沙坦中的有关物质。
中文关键词:阿齐沙坦  RP-HPLC  有关物质
 
Determination of the Related Substances in Azilsartan by RP-HPLC
Abstract:Objective To establish a HPLC method for the determination of related substances of azilsartan. Methods The determination was performed on a Agilent C18(250mm×4.6mm,5μm),with a mobile phase consisting of a mixture of acetonitrile,water and Acetic acid glacial by gradient elution.The flow rate and the detection were 0.8ml/min and 250nm respectively. Results Under the selected chromatographic conditions,related substances were completely separated from macitentan. The calibration curves for impurity A,impurity B,impurity C revealed good linearities over the ranges of 0.122-8.114mg/L(r=0.9999),0.121-8.064mg/L(r=0.9998),0.122-8.156mg/L(r=0.9993),respectively.The recoveries of the above compounds were 97.50% with RSD of 5.10%,96.82% with RSD of 3.02%,96.09% with RSD of 2.99%,respectively. Conclusion A specific method is established for determination of azilsartan related substances.
keywords:Azilsartan  RP-HPLC  Related substances
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