HPLC法测定盐酸喹那普利片有关物质  

HPLC determination of related substances in quinapril hydrochloride tablets

作　　者：毛士龙[1] 吴亚利[1] 张蓉蓉[1] 苗积康[1] 计英[1] 朱建民[1] 

机构地区：[1]上海市徐汇区中心医院,上海200031

出　　处：《药物分析杂志》2010年第6期1076-1079,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定盐酸喹那普利片有关物质的HPLC方法。方法:采用Agilent1200型高效液相色谱仪,色谱柱为AgilentXDBC18(250mm×4.6mm,5μm),流动相为甲醇-水-磷酸-二乙胺(60∶40∶0.13∶0.16),流速1.0mL·min-1,检测波长215nm,柱温40℃,进样量20μL。结果:盐酸喹那普利和已知杂质喹那普利环合物分别在1.084～32.52μg.mL-1和0.521～15.63μg.mL-1范围内与峰面积呈良好的线性关系;喹那普利环合物、各破坏性分解产物能和主峰分离,测得盐酸喹那普利最小检测限为2.134ng,喹那普利环合物最小检测限为2.156ng。结论:本方法准确、灵敏、可靠,专属性强,可用于盐酸喹那普利片的质量控制。Objective：To establish an HPLC method for determination of related substances in quinapril hydrochloride tablets.Methods：The HPLC method was performed on an Agilent 1200 liquid chromatography.Agilent XDB C18（250 mm×4.6 mm,5 μm）was adopted with the mobile phase of methanol-water-phosphoric acid-diethylamine（60∶40∶0.13∶0.16）.The flow rate was 1.0 mL·min-1 and the detection wavelength was set at 215 nm.The column temperature was set at 40 ℃ and the injection volume was 20 μL.Results：The linear ranges of quinapril hydrochloride and quinapril diketopiperazine were 1.084-32.52 μg·mL-1,0.5210-15.63μg·mL-1,respectively.The degradation substances and quinapril diketopiperazine could be separated from main peak.The lowest detectable limits of quinapril hydrochloride and quinapril diketopiperazine were 2.134 ng,2.156 ng,respectively.Conclusion：The method is simple,specific,and suitable for control of quinapril hydrochloride tablets.

关 键 词：盐酸喹那普利 有关物质 喹那普利环合物 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]