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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 determination method of the total amount of matrine and oxymatrine in the vagina effervescent tablet of FN. Methods: The column was eluted with an Agilent column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile - absolute ethanol - 3% phosphoric acid solution , Detection wavelength: 220 nm, column temperature: 30 ℃, external standard method. Results: Matrine and oxymatrine could be well separated from other impurities. Matrine had a good linearity (r = 0.999 9) in the range of 19.68 ~ 157.40μg · ml ~ (-1) The linear range of matrine was 25.25 ~ 202.00μg · ml ~ (-1) (r = 0.999 9). The recovery rate of matrine was 99.10% and the RSD was 1.11%. Oxymatrine plus The sample recovery was 99.01% with a RSD of 1.54%. Conclusion: The method can simultaneously and accurately determine the total amount of the two components, and is simple, accurate and fast, and can be used for the determination of batch samples and quality control.