RP-HPLC测定长春西汀冻干乳剂的含量及其有关物质

目的建立RP-HPLC进行长春西汀冻干乳剂的含量及有关物质测定方法,为原料与制剂的质量控制提供有效的分析方法。方法采用C18色谱柱（4.6mm×250mm,5μm）,流动相：甲醇-0.5%三乙胺溶液（84∶16,pH8）;检测波长：273nm;流速：1.0ml/min;柱温：室温。结果在选定的色谱条件下,长春西汀与有关物质分离完全;长春西汀在5～50μg/ml内,峰面积与质量浓度线性关系良好,相关系数r2=0.9998,检测限为20ng/ml;冻干乳中平均回收率为100.79%,相对标准差为0.67%（n=9）。结论本法简便、准确、专属性强,可用于长春西汀的有关物质检查及其冻干乳剂的含量测定。

Determination of vinpocetine and related substances in lyophilized submicroemulsion by RP-HPLC

Objective To determine the vinpocetine content and its related substances in lyophilized submicroemulsion of vinpocetine for quality control.Methods Separation was carried out on a C18 column（4.6 mm×250 mm,5 μm）,using a mobile phase of methanol-0.5% triethylamine（84∶16,pH8）at a flow rate of 1.0 ml/min.The ultraviolet detection wavelength was set at 273 nm.Results Under the established chromatographic conditions,the related substances and vinpocetine were separated completely.The method was validated and stability under various conditions was evaluated.The standard curve was linear within the range of 5-50 μg/ml with a correlation coefficient of 0.9998.The average recovery was 100.79%（RSD=0.67%,n=9）in lyophilized submicroemulsion.Conclusion This method is simple,specific and can be used for quality control of vinpocetine.