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

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,5.0 μm)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.