高效液相色谱法测定维胺酯有关物质和胶囊中维胺酯的含量

Determination of Related Substances and Viaminati in Viaminati Capsules by High Performance Liquid Chromatography

目的建立维胺酯胶囊含量测定及有关物质检查的高效液相色谱测定方法。方法采用高效液相色谱法,色谱柱:KromasilC18;流动相:乙腈-水(90∶10);流速:1.0ml/min;检测波长:370nm;柱温:20℃。结果维胺酯在0.045～0.45μg范围内与峰面积呈良好线性关系(r=1.000);维胺酯平均回收率99.1%,RSD为1.6%。有关物质含量在10%左右。结论该方法灵敏、专一、准确,可用于维胺酯胶囊中维胺酯的含量测定和有关物质检查。

Objective To establish a high performance liquid chromatography method for the determination of viaminati in Viaminati Capsules and related substances.Methods Separation was performed on a Kromasil C 18 column（4.6 mm×200 mm,5 μm）and the mobile phase was acetonitrile-water（90∶ 10）at a flow rate of 1.0 ml/min.The column temperature was set at 20℃ and the detective wavelength was at 370 nm.Results The linear range for viaminati was 0.045-0.45 μg（r=1.000）.The average recovery rate was 99.1%（RSD=1.6%）.The related substances were about 10%.Conclusion The method is sensitive,specific and accurate.It can be used for the determination of related substances and viaminati in Viaminati Capsules.