离子对RP-HPLC同时测定复方苦参注射液中氧化苦参碱、槐果碱和苦参碱的含量  

Ion-pair RP-HPLC simultaneous determination of oxymatrine, sophocarpine and matrine in compound Kushen injection

作　　者：赵亮[1] 韩利文[2,3] 欧扬[1] 方英立[1] 周文[1] 

机构地区：[1]山东大学齐鲁医院药剂科,济南250012 [2]山东省科学院生物研究所,济南250014 [3]天津中医药大学中药学院,天津1300193

出　　处：《药物分析杂志》2012年第7期1231-1234,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：山东省医药卫生科技发展计划项目(项目编号:2011QW015)

摘　　要：目的:建立同时测定复方苦参注射液中氧化苦参碱、槐果碱和苦参碱含量的方法。方法:采用离子对RP-HPLC法,色谱柱为Diamonsi C18(2)(250 mm×4.6 mm,5μm),流动相为乙腈-甲醇-水(35∶10∶55,水相中含5.5%磷酸和1.5%SDS),流速1.0 mL.min-1,检测波长220 nm,柱温为室温。结果:氧化苦参碱、槐果碱和苦参碱分别在9.92～99.2μg.mL-1(r=0.9991,n=5)、4.08～32.64μg.mL-1(r=0.9993,n=5)和20.16～161.28μg.mL-1(r=0.9996,n=5)范围内呈良好线性关系;平均回收率(n=6)分别为98.9%(RSD=1.2%),99.5%(RSD=1.4%)和100.2%(RSD=1.0%)。结论:本文建立的测定方法可应用于复方苦参注射液质量评价。Objective：To develop an RP - HPLC analytical method for simultaneous determination of matrine, oxymatrine and sophocarpine in compound Kushen injection. Methods ：The analysis was carried out using a column of Diamonsi C18（2） （250 mm ×4. 6 mm, 5μm） with a mobile phase of acetonitrile- methanol-water （35： 10：55, 5.5% phosphoric acid and 1.5% SDS in aqueous phase） , flow rate being 1.0 mL . min^-1, detection wavelength be- ing at 220 nm and the column temperature at room temperature. Results：The linear range was in the range of 9. 92 - 99. 2 μg . mL^-1 （r =0. 9991 ,n =5） for oxymatrine, in the range of 4. 08 -32. 64μg . mL-^1 （r =0. 9993, n =5） so- phocarpine and in the range of 20. 16 -161.28 μg . mL^-1（r =0. 9996, n =5） for matrine , respectively. The aver- age recoveries（n =6） of oxymatrine, sophocarpine and matrine were 98.9% （RSD = 1.2% ）, 99. 5% （RSD = 1.4% ） and 100. 2% （RSD = 1.0% ）, respectively. Conclusion：The method is found to be simple and accurate for simultane- ous analysis of oxymatrine, sophocarpine and matrine in compound Kushen injection for its quality evaluation.

关 键 词：复方苦参制剂 生物碱 苦参碱 氧化苦参碱 槐果碱 离子对反相高效液相色谱法 质量评价 标准提高 

分 类 号：R917[医药卫生—药物分析学]