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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,5.0μm)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 a method for the simultaneous determination of matrine, sophocarpine, oxycodone and oxymatrine in Compound Kushen Injection by reversed-phase ion pair chromatography. Methods: The chromatographic conditions were as follows: Diamonsil C18 (250 mm × 4.6 mm, 5.0 μm) column; the mobile phase consisted of 0.04% phosphoric acid-10 mmol·L-1 sodium pentanesulfonate aqueous solution and acetonitrile; The elution was performed at a flow rate of 1.2 mL · min-1. The column temperature was 30 ℃. UV detection wavelength was 210 nm. Results: The concentrations of matrine, sophocarpine, oxycodone and oxymatrine were good linearity in the range of 18.92 ~ 946.0,4.052 ~ 202.6,9.293 ~ 464.6 and 34.73 ~ 1736 mg · L-1, respectively The coefficients were all 0.9999; the content of four alkaloids in RSD repeatability test was less than 2.1%; the average recoveries were 98.2%, 96.4%, 96.9% and 97.1% respectively. Conclusion: The method is simple, accurate, reproducible and can be used for the quality control of compound Kushen injection.