反相离子对色谱法同时测定复方苦参注射液中4个生物碱含量  

Ion-pair RP-HPLC simultaneous determination of four alkaloids in compound Kushen injection

作　　者：陈晨[1] 瞿海斌[1] 郝润才 董迷柱 李安平 邵青[1] 

机构地区：[1]浙江大学药物信息学研究所,杭州310058 [2]山西振东制药股份有限公司,长治047100

出　　处：《药物分析杂志》2012年第6期1006-1009,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：重大新药创制"国家科技重大专项"(2008ZX09202-009)

摘　　要：目的:建立反相离子对色谱同时测定复方苦参注射液中苦参碱、槐果碱、氧化槐果碱和氧化苦参碱含量的方法。方法:色谱条件:Diamonsil C18(250 mm×4.6 mm,5.0μm)色谱柱;流动相为0.04%磷酸-10 mmol·L-1戊烷磺酸钠水溶液(A)和乙腈(B),线性梯度洗脱,流速为1.2 mL·min-1;柱温为30℃;紫外检测波长:210 nm。结果:苦参碱、槐果碱、氧化槐果碱和氧化苦参碱质量浓度分别在18.92～946.0,4.052～202.6,9.293～464.6,34.73～1736 mg·L-1范围内线性关系良好,相关系数均为0.9999;RSD重复性试验中4个生物碱含量均小于2.1%;平均加样回收率分别为98.2%,96.4%,96.9%,97.1%。结论:该方法简便、准确,重复性好,可用于复方苦参注射液的质量控制。Objective：To establish an ion-pair RP-HPLC method for the simultaneous determination of matrine,sophocarpine,oxysophocarpine and oxymatrine contents in compound Kushen injection.Methods：The chromatographic separation was carried out with a Diamonsil C18 column（250 mm×4.6 mm,5.0 μm）.The mobile phase was composed of solvent A（0.04%phosphoric acid and 10 mmol·L-1 sodium pentanesulfonate in water） and solvent B（acetonitrile） with linear gradient elution at a flow rate of 1.2 mL·min-1.The column temperature was 30 ℃.The detection wavelength was 210 nm.Results：The calibration curves had good linear for matrine,sophocarpine,oxysophocarpine,and oxymatrine in the range of 18.92-946.0 mg·L-1,4.052-202.6 mg·L-1,9.293-464.6 mg·L-1 and 34.73-1736 mg·L-1,respectively.The values of correlation coefficient were 0.9999.Repeatability experiments showed that RSD values of the 4 contents were all less than 2.1%.The average recoveries of matrine,sophocarpine,oxysophocarpine and oxymatrine were 98.2%,96.4%,96.9%,97.1%,respectively.Conclusion：The method is simple,accurate and good reproducibility,which can be used for quality control of Compound Kushen injection.

关 键 词：复方苦参注射液 反相离子对色谱 苦参碱 槐果碱 氧化槐果碱 氧化苦参碱 多组分分析 质量控制 

分 类 号：R917[医药卫生—药物分析学]