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HPLC法测定妇宁阴道泡腾片中苦参碱和氧化苦参碱的总量
引用本文:梁亚丽,郭文敏,王莉芳,李清娟. HPLC法测定妇宁阴道泡腾片中苦参碱和氧化苦参碱的总量[J]. 中国药师, 2010, 13(10): 1411-1413
作者姓名:梁亚丽  郭文敏  王莉芳  李清娟
作者单位:石药集团中奇制药技术(石家庄)有限公司,石家庄050051
基金项目:科技部"十一五"重大新药创制"石药集团创新药物研制产学研联盟建设"
摘    要:目的:建立妇宁阴道泡腾片中苦参碱和氧化苦参碱的总量测定方法。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(85:7.5:7.5),流速:1.0ml·min^-1,检测波长:220nm,柱温:30℃,外标法测定。结果:苦参碱、氧化苦参碱与其他杂质之间能够达到很好分离;苦参碱在19.68~157.40μg·ml^-1浓度范围内线性关系良好(r=0.9999);氧化苦参碱在25.25—202.00μg·ml^-1浓度范围内线性关系良好(r=0.9999);苦参碱的加样回收率为99.10%,RSD为1.11%;氧化苦参碱加样回收率为99.01%,RSD为1.54%。结论:该法能够同时准确测定两组分的总量,而且简便、准确、快速,可用于批次样品的含量测定及质量控制。

关 键 词:苦参碱  氧化苦参碱  阴道泡腾片  含量测定  高效液相色谱法

Determination of Matrine and Oxymatrine in Funing Vaginal Effervescent Tablets by HPLC
Liang Yali,Guo Wenmin,Wang Lifang,Li Qingjuan. Determination of Matrine and Oxymatrine in Funing Vaginal Effervescent Tablets by HPLC[J]. China Pharmacist, 2010, 13(10): 1411-1413
Authors:Liang Yali  Guo Wenmin  Wang Lifang  Li Qingjuan
Affiliation:( CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. ,Ltd, Shijiazhuang 050051, China)
Abstract:Objective: To establish the method for determination of matrine and oxymatrine in funing vaginal effervescent tablets. Method: Matrine and oxymatrine were separated on a Agilet amino column (250 mm × 4. 6 mm ,5 μm). The mobile phase was consisted of acetanitrile and ethanol absolute and 3.0% sulphuric acid (85: 7.5: 7. 5 )at a flow rate of 1.0 μg·ml^-1 and the column temperature at 30 ℃. The detection wavelength was 220 nm. Result: The resolution of matrine, oxymatrine, and other ingredients were good. The linear calibration curves were obtained over the range of 19. 68-157.40 μg·ml^-1 for matrine (r =0. 999 9) and 25. 25-202. 00 μg·ml^-1 for oxymatrine (r =0. 999 9) respectively. The mean recoveries of matrine and oxymatrine were 99. 10% with RSD 1.11% and 99. 01% with RSD 1.54%, respectively. Conclusion: This method is simple, rapid, accurate, and suitable for quality control of large amounts of samples.
Keywords:Matrine  Oxymatrine  Vaginal effervescent tablets  Determination  HPLC
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