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作 者:欧阳文轩 Ouyang Wenxuan(Jiangsu Kangyuan Yangguang Pharmaceutical Co.,Ltd,Nanjing 210046,China)
机构地区:[1]江苏康缘阳光药业有限公司,江苏南京210046
出 处:《亚太传统医药》2019年第9期38-41,共4页Asia-Pacific Traditional Medicine
摘 要:目的:建立通塞脉片中β-蜕皮甾酮含量测定方法,通过测定β-蜕皮甾酮含量进一步提高通塞脉片质量标准。方法:采用高效液相色谱法(HPLC法)测定,选用WondasilC(18)(4.6 mm×250 mm,5μm)岛津色谱柱,流动相为乙腈-水-甲酸(15:85:0.1),检测波长选用250 nm,流速为1.0 mL/min,柱温为35℃,进样量为10μL。结果:通过此方法通塞脉片中β-蜕皮甾酮能得到较好分离,β-蜕皮甾酮线性范围为0.5034~1.1075μg,r=0.999 8(n=6),得到平均回收率为96.86%,RSD值为1.14%。结论:用高效液相色谱法进行测定操作简单快捷,实验结果准确性高、重复性好,可用于通塞脉片中β-蜕皮甾酮的含量测定。Objective:To establish an HPLC method to determinate the content of p-ecdysterone in Tongsaimai tablet and improve the quality standard of Tongsaimai tablet.Methods:Use high performance liquid chromatography ( HPLC) to determinate.HPLC method was that using Wondasil C18 (4.6mm×250mm,5μm)chromatographic column,acetonitrile-water-formic acid solution(15:85:0.1)as mobile phase.The UV detector wavelength was set at 250 nm and the flow rate was 1.0mL/min.The column temperature was set at 35℃ and sample volume was 10μL.Results:The results are as follows.According to analyzing,the components were separated in 40min by HPLC method.Epigotrin solution had a good linear relationship within the range of 0.503 4-1.1075μg (r=0.9998,n=6);The average recovery was 96.86% and the results of theRSD was 1.14%.Conclusion:The determination method by using HPLC is simple and rapid.The determination result is high-accurate and has a good reproducibility.This method can be used for determination of p-ecdysterone content in Tongsaimai tablet and the quality control of Tongsaimai tablet.
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