HPLC法测定长春胺缓释胶囊的含量及有关物质  

Assay of Vincamine Sustained Release Capsules and Its Related Substances by HPLC

作　　者：李婷婷[1,2] 李洁[2] 陈杰[2] 张楠[1] 

机构地区：[1]郑州大学,郑州450001 [2]河南省食品药品检验所,郑州450003

出　　处：《中国药品标准》2016年第5期331-333,共3页Drug Standards of China

摘　　要：目的:建立HPLC法测定长春胺缓释胶囊的含量及有关物质。方法:采用Agela Durashell C18(L)色谱柱(4.6 mm×250mm,5μm),流动相为乙腈-0.1 mol·L^(-1)碳酸铵溶液(65∶35),流量为1.0 m L·min^(-1),柱温为30℃,检测波长为280 nm。结果:在选定的色谱条件下,主成分峰与各杂质峰之间的分离度良好,长春胺在9.66~72.48μg·m L^(-1)的浓度范围内与其峰面积呈良好的线性关系(r=0.999 9),平均回收率为100.27%,其RSD=0.81%(n=9)。结论:所建方法快速简便,灵敏度高,专属性强,可用于长春胺缓释胶囊的质量控制。Objective：To establish an HPLC method for the assay of Vincamine Sustained Release Capsules and its related substances. Method：The determination was performed on an Agela Durashell CIs （L） column （4. 6 mm × 250 mm,5 μm） with a mobile phase consisted of acetonitrile -0. 1 mol . L-1 ammonium carbonate solution （65：35 ） at the flow rate of 1.0 mL . min-1. The column temperature was set at 30 ℃ and detection wavelength was 280 nm. Results ：The related substances were completely separated from the main constituent. The linear rang of Vincamine was 9. 66 -72.48 μg . mL-1 （r =0. 999 9）, the average recovery was 100. 27% with RSD of 0. 81% （n = 9）. Conclusion：The method is simple, accurate and sensitive, which can be used to control the quality of Vincamine Sustained Release Capsules.

关 键 词：长春胺缓释胶囊 含量测定 有关物质 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]