吴桂芳 童红 （贵州省药品检验所 贵阳 550004） 申刚 （贵州科辉制药有限责任公司） 李琴 （贵州山宝药业有限责任公司）
摘 要 目的：建立妇得康泡沫剂中苦参碱及氧化苦参碱含量的测定方法。
方法：采用HPLC法，色谱柱Diamonsil C18(200 mm×4.6 mm,5 μm),用乙腈-无水乙醇-3%磷酸溶液（86∶10∶4）为流动相，检测波长为220 nm。
结果：苦参碱在0.024 5～0.220 5 μg范围内呈良好线性关系(r=0.999 9)，平均加样回收率为98.58%，RSD为0.30%（n=6）；氧化苦参碱在0.217～1.953 μg范围内呈良好线性关系(r=0.999 7)，平均加样回收率为99.32%，RSD为0.97%（n=6）。结论：本方法简便、快速准确、重复性好，可用于该制剂质量控制。
关键词 妇得康泡沫剂;高效液相色谱;苦参碱;氧化苦参碱
中图分类号：R927.2
文献标识码：A
文章编号：1008-049X(2007)10-0989-03
Determination of Matrine and Oxymatrine in Fudekang Foaming Agent by HPLC
Wu Guifang,Tong Hong (Institute for Drug Control of GuiZhou，Guiyang 550004, China);Shen Gang (Guizhou Kehui Pharmaceutical CO.Ltd.);Li qin(Guizhou Shanbao Pharmaceatical CO.Ltd)
ABSTRACT Objective:To establish an HPLC method for simultaneous determination of Matrine and Oxymatrine in Fudekang Foaming Agent.Method: Diamonsil C18 column（200 mm×4.6 mm,5 μm） was used.Mobile phase consisted of acetontrileethanol 3% phosphoric acid(86∶10∶4).The detection wavelength was at 220 nm.Result: The calibration curve of Matrine was linear within the range of 0.0245～0.2205 μg(r=0.999 9).The average recoveries of Matrine was 98.58%,RSDwas 0.30%(n=6).The calibration curve of Oxymatrine was linear within the range of 0.217～1.953 μg(r=0.999 7).The average recoveries of Oxymatrine was99.32%,RSDwas 0.97%(n=6).Conclusion:The method is simple,fast,accurate,realizable and reproducible,it can be used to control the quality of Fudekang Foaming Agent.
KEY WORDS Fudekang Foaming Agent;HPLC; Matrine; Oxymatrine
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1 中国药典［S］.2005年版.一部.141
2 李培凡，王智，沈彬，等.反相高效液相色谱法同时测定苦参碱、氧化苦参碱、槐果碱和槐胺碱的含量［J］.时珍国医国药，2004，15（02）:76-77
3 费艳秋，安富荣，梁贤振，等.HPLC法同时测定人血浆中苦参碱和氧化苦参碱含量［J］.中国药房，2001,12（08）:479-480 资料来自:中国药师-专业站 |