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

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

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Hypersil ODS2色谱柱（200mm×4．6mm，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33mmo·L^-1的SDS）。检测波长为210nm，柱温为室温。结果氧化槐果碱质量浓度在2．52～50．4mg·L^-1内与峰面积呈良好线性关系，r=0．9999（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17．44-174．4mg·L^-1内与峰面积呈良好线性关系。r=0．9997（n=6），平均回收率为99．5％，RSD为2．2％（n=9）；苦参碱质量浓度在1．96～39．20mg·L^-1内与峰面积呈良好线性关系，r=0．9997（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。

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 tem- perature was 25℃. Results The linear range of oxysophocarpine was 2.52-50.4 mg· L^-1, oxymatrine was 17.44-174.4 mg· L^-1 and matrine was 1.96-39.20 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.