HPLC法测定恩替卡韦分散片中恩替卡韦的含量  

Determination of Entecavir in Entecavir Dispersible Tablets by HPLC

作　　者：易毛[1] 韩晋[1] 吴素体[1] 张诗龙[1] 谢进[1] 李正明[1] 刘峰群[1] 丁晋彪[2] 楼金芳 

机构地区：[1]解放军302医院药学部,北京100039 [2]解放军302医院医务部,北京100039 [3]杭州盛友医药技术开发有限公司,浙江杭州310018

出　　处：《解放军药学学报》2012年第6期520-522,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立HPLC法测定恩替卡韦分散片中恩替卡韦含量的方法。方法采用HPLC梯度洗脱法测定恩替卡韦的含量,色谱柱采用C18为填充剂(4.6 mm×150 mm,5μm);流动相A:水-乙腈-三氟乙酸(990∶10∶1),流动相B:水-乙腈-三氟乙酸(700∶300∶1),梯度洗脱法;检测波长254 nm;流速1.0 ml.min-1;柱温:25℃。结果恩替卡韦浓度在21～50μg.ml-1(r=0.9992)范围内线性关系良好,平均加样回收率为99.14%,RSD为0.15%。结论本方法操作简单,专属性强,重复性好,可用于恩替卡韦分散片中恩替卡韦的含量测定。Objective To establish an HPLC quantitative method for dispersible tablets. Methods HPLC was used for determining the content of determination of entecavir in entecavir entecavir with linear gradient elution. The chromatography column was Cls （ 4.6 mm X 150 mm, 5 μm） ;The first mobile phase consisted of water-aceto- nitrile-trifluoroacetic acid （990： 10：1 ） solution while the second mobile phase was water-acetonitrile-trifluoroacetic acid （700： 300：1 ） solution. The flow rate was 1.0 ml .min-1 and the detection wavelength was set at 254 nm. The column temperature was 25 ℃Results The linear range of entecavir was 21-50 μg .m1-1 （ r =0. 9992）. The average recovery of enticavir was 99.14% and RSD was 0.15%. Conclusion This method is simple, specific and reproducible, which can be used to determine entecavir in entecavir dispersible tablets.

关 键 词：HPLC 恩替卡韦分散片 恩替卡韦 

分 类 号：R927.2[医药卫生—药学]