中国药物警戒 ›› 2011, Vol. 8 ›› Issue (12): 709-710.

• 基础及临床研究 • 上一篇    下一篇

RP-HPLC测定蕲龙胶囊中华蟾酥毒基和酯蟾毒配基的含量

唐晓霞, 李萍, 吴菲   

  1. 江苏济川制药有限公司,江苏 泰兴 225441
  • 收稿日期:2011-09-07 出版日期:2011-12-10 发布日期:2015-07-30
  • 作者简介:唐晓霞,女,质量工程师,中药分析。

Contents Determination of Cinobufagin and Resibufogenin in Shuanglong Capsule by RP-HPLC

TANG Xiao-xia, LI Ping, WU Fei   

  1. Jiangsu Jumpcan Pharmaceutical Limited Company, Jiangsu Taixing 225441, China
  • Received:2011-09-07 Online:2011-12-10 Published:2015-07-30

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摘要： 目的 建立蕲龙胶囊中华蟾酥毒基和酯蟾毒配基的含量测定方法。方法 采用高效液相色谱法,Phenomenex luna C18（250 mm×4.6 mm,5μm)色谱柱,流动相为乙腈-水（50:50）,流速0.8 mL/min,检测波长296 nm。结果 方法学考察结果表明,本研究建立的分析方法有较好的重现性和稳定性。华蟾酥毒基平均加样回收率为98.5%（RSD=0.55%,n=6）;酯蟾毒配基平均加样回收率为101.0%（RSD=0.67%,n=6）。结论 本方法定量准确、重复性好,可用该制剂的质量控制。

关键词: 蕲龙胶囊, 华蟾酥毒基, 酯蟾毒配基, RP-HPLC, 含量测定

Abstract: Objective To develop a method for the content determination of cinobufagin and resibufogenin in shuanglong capsule. Methods Analysis was carried out on a Phenomenex luna C18(250 mm×4.6 mm, 5μm) column, the mobile phase was acetonitrile water(50:50,v/v) at the flow rate of 0.8mL·min-1, and the detection wavelength was set at 296nm. Results The result showed that the method of analysis established in this study have good reproducibility and stability. The cinobufagin average recovery was 98.5% (RSD=0.55%,n=6); The resibufogenin average recovery was 101.0%(RSD=0.67%,n=6). Conclusion The method is accurate and repeatable, and it can be applied to control the quality of this drug.

Key words: Qilong capsule, cinobufagin, resibufogenin, RP-HPLC, assay

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