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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。
OBJECTIVE To establish RP-HPLC for the determination of vinpocetine freeze-dried emulsion and its related substances, and to provide an effective analytical method for the quality control of raw materials and preparations. Methods C18 column (4.6mm × 250mm, 5μm) was used. The mobile phase was methanol-0.5% triethylamine solution (84:16, pH8). The detection wavelength was 273nm. The flow rate was 1.0ml / min. Results Under the selected chromatographic conditions, vinpocetine was completely separated from the related substances. The vinpocetine showed a good linear relationship with the mass concentration in the range of 5 ~ 50μg / ml, the correlation coefficient r2 = 0.9998, the detection limit was 20ng / ml The average recovery of freeze-dried milk was 100.79% with a relative standard deviation of 0.67% (n = 9). Conclusion This method is simple, accurate and specific and can be used for the determination of vinpocetine and its content of freeze-dried emulsion.