RP-HPLC法测定阿齐沙坦的有关物质  

Determination of the Related Substances in Azilsartan by RP-HPLC

作　　者：吴标 王娟 崔红晓 潘显道[2] 

机构地区：[1]合肥久诺医药科技有限公司,230088 [2]中国医学科学院/北京协和医学院,100050

出　　处：《医学研究杂志》2017年第3期178-181,共4页Journal of Medical Research

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 C_(18)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。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.

关 键 词：阿齐沙坦 RP—HPLC 有关物质 

分 类 号：R9[医药卫生—药学]