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

目的建立复方苦参注射液中氧化槐果碱、氧化苦参碱和苦参碱的含量测定方法。方法Hy-persil ODS2色谱柱(200 mm×4.6 mm,5μm),流动相为甲醇-乙腈水磷酸(体积比为10.00∶30.00∶65.00∶0.05,含33 mmol.L-1的SDS),检测波长为210 nm,柱温为室温。结果氧化槐果碱质量浓度在2.52~50.4 mg.L-1内与峰面积呈良好线性关系,r=0.999 9(n=6),平均回收率为98.2%,RSD为1.8%(n=9);氧化苦参碱质量浓度在17.44~174.4 mg.L-1内与峰面积呈良好线性关系,r=0.999 7(n=6),平均回收率为99.5%,RSD为2.2%(n=9);苦参碱质量浓度在1.96~39.20 mg.L-1内与峰面积呈良好线性关系,r=0.999 7(n=6),平均回收率为102.3%,RSD为2.0%(n=9)。结论测定方法可作为复方苦参注射液质量控制方法。

Simultaneous RP-HPLC determination of oxysophocarpine oxymatrine and matrine in compound kushen injection

Objective To establish a RP-HPLC method for simultaneous determination of oxysophocarpine,oxymatrine and matrine in compound kushen injection.Methods The column of Hypersil ODS2(4.6 mm×200 mm,5 μm) was used,the mobile phase was methanol-acetonitrile-water-phosphoric acid(V∶V∶V∶(V=)10∶30∶65∶0.05,33 mmol·L~(-1) SDS),the detection wavelength was set at 210 nm and the column temperature was 25℃.Results The linear range of oxysophocarpine was 2.5250.4 mg·L~(-1),oxymatrine was 17.44174.4 mg·L~(-1) and matrine was 1.9639.20 mg·L~(-1) respectively.The average recoveries of oxysophocarpine,oxymatrine and matrine were 98.2% with RSD 1.8%,99.5% with RSD 2.2% and 102.3% with RSD 2.0%(n=9).Conclusions The method is accurate,sensitive and suitable for the quality control of compound kushen injection.