| 李婷婷,李洁,陈杰,张楠.HPLC法测定长春胺缓释胶囊的含量及有关物质[J].中国药品标准,2016,17(5):331-334 |
| 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 Test for Related Substances by HPLC |
| 投稿时间：2016-06-07 修订日期：2016-08-31 |
| DOI： |
| 中文关键词: 长春胺 缓释胶囊 含量测定 有关物质 高效液相色谱法 |
| 英文关键词: Vincamine Sustained Release Capsules assay related substance HPLC |
| 基金项目: |
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| 中文摘要: |
| 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(250 mm×4.6 mm，5 μm），流动相为乙腈-0.1mol?L-1碳酸铵溶液（65︰35），流量为1.0 mL?min-1，柱温为30℃，检测波长为280nm。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9.66~72.48 μg?mL-1的浓度范围内与其峰面积呈良好的线性关系（r=0.9999），平均回收率为100.34%，其RSD=0.75% (n=9)。结论:本方法快速简便、灵敏度高，专属性强，可用于长春胺缓释胶囊的质量控制。 |
| 英文摘要: |
| Objective: To establish an HPLC method for the assay of Vincamine Sustained Release c apsules and its related substances. Method: The determination was performed on an Agela Durashell C18(L) column (250 mm×4.6 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 280nm. Results: The related substances were completely separated from the main constituent. The linear rang of Vincamine was 9.66-72.48μg?mL-1 (r=0.999 9), the average recovery was 100.27% with RSDof 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. |
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