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

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,5 μm),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9.92~99.2 μg·mL^-1(r=0.9991,n=5)、4.08~32.64 μg·mL^-1(r=0.9993,n=5)和20.16~161.28 μg·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, 5 μm) 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 being 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 4.08-32.64 μg·mL^-1(r=0.9993, n=5) sophocarpine and in the range of 20.16-161.28 μg·mL^-1(r=0.9996, n=5) for matrine, respectively. The average 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 simultaneous analysis of oxymatrine, sophocarpine and matrine in compound Kushen injection for its quality evaluation.