HPLC法测定妇宁阴道泡腾片中苦参碱和氧化苦参碱的总量

Determination of Matrine and Oxymatrine in Funing Vaginal Effervescent Tablets by HPLC

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(250 mm×4.6mm,5μm),流动相:乙腈-无水乙醇-3%磷酸溶液(85:7.5:7.5),流速:1.0 ml·min^(-1),检测波长:220 nm,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=0.999 9);氧化苦参碱在25.25～202.00μg·ml^(-1)浓度范围内线性关系良好(r=0.999 9);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。

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.