离子对RP-HPLC同时测定复方苦参注射液中氧化苦参碱和苦参碱含量

Simultaneous ion pair RP-HPLC determination of oxymatrine and matrine in Compound Kushen Injection

目的 :建立同时测定复方苦参注射液 (苦参、白土茯苓 )中氧化苦参碱和苦参碱含量的方法。方法 :采用离子对RP HPLC法 ,HypersilODS2 色谱柱 (2 0 0mm× 4 .6mm ,5 μm) ,流动相为甲醇 乙腈 水 磷酸 (1 0∶30∶6 5∶0 .0 5 ,含 33mmol·L-1 的SDS) ,流速 1 .0mL·min-1 ,检测波长 2 1 0nm ,柱温为室温。结果 :氧化苦参碱、苦参碱分别在 1 7.4 4～ 1 74 .4 μg·mL-1 (r =0 .9996 ,n =6 )和 1 .96～ 39.2 0 μg·mL-1 (r =0 .9997,n =6 )范围内呈良好线性关系 ;平均回收率分别为 1 0 0 .4 %(RSD =2 .1 %,n =9)和 99.7%(RSD =1 .4 %,n =9)。结论 :本测定方法简便、快速、准确 ,为复方苦参注射液质量评价提供了可靠方法。

AIM: A RP HPLC was developed to determine the contents of oxymatrine and matrine simultaneously in Compound Kushen Injection(Radix Sophorae Flavescentis, Rhizoma Heterosmilacis Japonicae). METHODS: The analysis was carried out on a column of Hypersil ODS 2(4.6mm×200mm,5μm) with a mobile phase of methanol acetonitrile water phosphate acid(10∶30∶65∶0.05,33mmol·L -1 ), flow rate being 1.0mL·min -1 , detection wavelength being at 210nm and the column temperature at room temperature. RESULTS: The linear range was in the range of 17.44～174.4μg·mL -1 ( r =0.9996, n =6) for oxymatrine and in the range of 1.96～ 39.20 μg·mL -1 ( r=0.9997,n =6) for matrine, respectively. The average recoveries of oxymatrine and matrine were 100.4%( RSD =2.1%, n =9) and 99.7%( RSD =1.4%, n =9), respectively. CONCLUSION: The method is found to be simple and accurate for simultaneous analysis of oxymatrine and matrine in Compound Kushen Injection, and a reliable way to quality evaluation.