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目的:建立心律宁片中苦参碱、氧化苦参碱的含量测定方法。方法:高效液相色谱法。以Agilent NH2色谱柱(4.6×250mm,5um)为分析术,柱温:23～30℃,以乙腈-无水乙醇-3%磷酸(80:10:10)为流动相;检测波长为220nm。结果:苦参碱进样量在0.104μg～0.624μg范围内时与峰面积有良好的线性关系,r苦=0.9999,平均加样回收率=100.39% RSD%=1.18。氧化苦参碱进样量在0.324μg～1.944μg范围内时与峰面积有良好的线性关系,r氧=0.9999,平均加样回收率102.91 RSD%=1.58。结论:该方法灵敏、简便,结果准确,重现性好,适用于心律宁片的质量控制。
Objective: To establish a method for the determination of matrine and oxymatrine in Xinfuning tablets. Method: High performance liquid chromatography. Agilent NH2 column (4.6×250mm, 5um) was used for analysis. The column temperature was 23～30°C and the mobile phase was acetonitrile-anhydrous ethanol-3% phosphoric acid (80:10:10). The detection wavelength was 220 nm. Results: There was a good linear relationship with the peak area when the amount of matrine injected was in the range of 0.104μg～0.624μg, r = 0.9999, and the average sample recovery was 100.39% RSD% = 1.18. When the amount of oxymatrine injection was in the range of 0.324 μg to 1.944 μg, there was a good linear relationship with the peak area, r = 0.9999, and the average recovery was 102.91 RSD% = 1.58. Conclusion: This method is sensitive, simple, accurate and reproducible. It is suitable for the quality control of Xinxinning tablets.