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中国药物评价 ›› 2022, Vol. 39 ›› Issue (4): 318-321.

• 评价技术与方法 • 上一篇    下一篇

HPLC法测定分析痢泻灵片中苦参碱及 氧化苦参碱的含量

于远洋, 鄢长余, 刘娜, 牛玉娟*   

  1. 大连市检验检测认证技术服务中心, 辽宁 大连 116021
  • 收稿日期:2022-04-08 修回日期:2022-07-26 出版日期:2022-08-28 发布日期:2022-10-08
  • 基金资助:
    2019年国家药典委员会标准修订研究项目(项目编号:2019Z052 ;项目名称:痢泻灵片 )

Determination and Analysis of Matrin and Oxymatrin in Li xie ling Tablet by HPLC

  1. Dalian inspection and Certification Technology Service Center, Liaoning Dalian 116021, China
  • Received:2022-04-08 Revised:2022-07-26 Online:2022-08-28 Published:2022-10-08

摘要: 目的:建立高效液相色谱法测定痢泻灵片中苦参碱和氧化苦参碱的含量,并对市售产品进行分析评价。方法:采用高效液相色谱法,symmetry C18色谱柱(5 μm,4.6 mm×250 mm),以乙腈-磷酸盐缓冲液(2∶98)为流动相等度洗脱,测定痢泻灵片中苦参碱及氧化苦参碱的含量,柱温30 ℃,流速0.8 mL·min-1,检测波长:220 nm。结果:痢泻灵片中苦参碱、氧化苦参碱两个成分峰均可达到基线分离,分别在0.395 6~6.328 8 μg(r=1.000 0),0.355 8~5.692 2 μg(r=1.000 0)范围内呈良好线性关系,平均加样回收率分别为99.32%、98.03%。结论:本方法简便,专属,实用,适合于痢泻灵片中的苦参碱和氧化苦参碱的含量测定,可以有效地控制产品的质量,通过检测结果分析:市售产品每片含量结果在0.32~1.50 mg之间不等,表明各企业产品质量差异较大。
    

关键词: font-size:medium, ">痢泻灵片;苦参;苦参碱;氧化苦参碱;含量测定;高效液相色谱

Abstract: Objective:Toestablish an HPLC method for the determination of matrin andoxymatrin in Li xieling tablet,analyze and evaluate the market products. Methods:High performance liquid chromatography was used to examine the contents of matrine and oxymatrine in Lixieling tablets,Using symmetry C18 column(5 μm,4.6 mm×250 mm),the mobile phase was acetonitrile(A)-0.2% phosphate buffer (B) with gradient elution at a flow rate of 0.8 mL·min-1, The temperature for chromatographic column was 30 ℃ and the detection wavelength was 220 nm.Results:Baseline separation can be achieved for matrin,oxymatrin in Li xie ling tablet. The method had a good linearity in the ranges of 0.395 6~6.328 8(r=1.000 0),0.355 8~5.692 2 μg(r=1.000 0),The average recoveris(n=6) were99.32%、98.03%.Conclusion:Thisassay isproved to be reproducible,spefic and practical.It is suitable for the determination of matrine and oxymatrine in Lixieling tablets, and can effectively control the product quality.Between 0.32 and 1.50mg, it showed that the quality of the products among the different manufacturing enterprises was greatly different.

Key words: Li xie ling tablet, Radix sophorae flavescentis, Matrin, Oxymatrin;Content determination, HPLC

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