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目的:建立高效液相色谱法测定月矾中空栓制剂中氧化苦参碱和苦参碱含量的方法。方法:采用Phenomenex ODS-C18(4.6 mm×250 mm,5μm)色谱柱;流动相为0.1%磷酸溶液-乙腈-甲醇(75∶20∶5);流速1.0 mL·min-1;检测波长205 nm;柱温为室温;进样量10μL。结果:氧化苦参碱和苦参碱分别在0.169~1.69μg(r=0.9996)和0.270~2.70μg(r=0.9997)范围内,含量与峰面积呈良好的线性关系;氧化苦参碱和苦参碱的平均加样回收率分别为101.2%(RSD为1.5)和100.3%(RSD为1.9)(n=5)。结论:该方法简便快速,准确可靠,适用于测定月矾中空栓中氧化苦参碱和苦参碱的含量,从而有效控制该制剂质量。
Objective: To establish a method for the determination of oxymatrine and matrine in alum hollow suppository by high performance liquid chromatography. METHODS: Phenomenex ODS-C18 column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase was 0.1% phosphoric acid solution-acetonitrile-methanol ; Column temperature was room temperature; injection volume 10μL. Results: The concentrations of oxymatrine and matrine ranged from 0.169 to 1.69 μg (r = 0.9996) and 0.270 to 2.70 μg (r = 0.9997), respectively. The content of oxymatrine and matrine showed a good linear relationship with the peak area. The average recoveries of the reference bases were 101.2% (RSD 1.5) and 100.3% (RSD 1.9) (n = 5), respectively. Conclusion: The method is simple, rapid, accurate and reliable. It is suitable for the determination of oxymatrine and matrine in the alum hollow suppository, so as to effectively control the quality of the preparation.