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用HPLC法测定马来酸依那普利片的含量和有关物质
引用本文:刘浩. 用HPLC法测定马来酸依那普利片的含量和有关物质[J]. 药学服务与研究, 2003, 3(4): 247-249
作者姓名:刘浩
作者单位:上海市药品检验所,上海,200233
摘    要:目的:采用改进的HPLC法测定马来酸依那普利片中马来酸依那普利和有关物质的含量。方法:采用HypersilBDS C8色谱柱(250 mm×4.0 mm,5μm ID);0.001 mol/L磷酸二氢铵溶液(用磷酸调节pH值至2.0)-甲醇(60:40);检测波长215 nm。结果:马来酸依那普利在0.1~0.3 mg/ml范围内线性关系良好(r=0.999 9);方法的平均回收率为99.8%。依那普利与有关物质之间分离良好。结论:本法有较高的回收率、精密度和重现性。

关 键 词:马来酸依那普利 有关物质 色谱法 高压液相
文章编号:1671-2838(2003)04-0247-03
修稿时间:2003-02-12

Determination of contents of enalapril maleate and its related substances by HPLC method
LIU Hao. Determination of contents of enalapril maleate and its related substances by HPLC method[J]. Pharmaceutical Care and Research, 2003, 3(4): 247-249
Authors:LIU Hao
Abstract:Objective: To optimize HPLC method of determinating content of enalapril maleate and related substances. Methods: The Hypersil BDS C8 column was used with the mobile phase of 0. 001 mol/L phosphate buffer (adjusted pH to 2. 0 with phosphoric acid)-methanol (60 : 40). The detection wavelength was 215 nm. Results: The linear range was 0. 1 - 0. 3 mg/ml (r=0. 999 9). The average recovery rate was 99.8%. Enalapril and related substances were well separated. Conclusion : The recovery rate, precision and reapprearance of the method are higher.
Keywords:enalapril maleate) related substances  chromatography   high pressure liquid
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