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目的:建立康艾注射液中氧化苦参碱含量的高效液相测定方法。方法:色谱柱:Agilent氨基柱(250mm×4.6mm,5μm),流动相:乙腈-无水乙醇-3%磷酸溶液(80:10:10),检测波长:220nm,柱温:30℃,流速:1.0ml·min~(-1)。结果:氧化苦参碱线性范围为5.63～28.15μg(r=0.999 8),平均回收率为100.6%,RSD=0.29%(n=7)。结论:本法简便,准确,重复性好,可用于康艾注射液的质量控制。
Objective: To establish an HPLC method for the determination of oxymatrine in Kangai injection. Methods: The column was Agilent column (250mm × 4.6mm, 5μm), the mobile phase consisted of acetonitrile-absolute ethanol-3% phosphoric acid solution (80:10:10), the detection wavelength was 220nm, the column temperature was 30 ℃, : 1.0 ml · min ~ (-1). Results: The linear range of oxymatrine was 5.63-28.15 μg (r = 0.999 8). The average recovery was 100.6% with RSD = 0.29% (n = 7). Conclusion: This method is simple, accurate, reproducible and can be used for the quality control of Kangai injection.