RP-HPLC法测定长春西汀葡萄糖注射液的有关物质及长春西汀的含量.docVIP

RP-HPLC法测定长春西汀葡萄糖注射液 袁利杰，陈杰，杨本霞，郑子栋（河南省食品药品检验所，郑州 450003） 摘要 目的: 建立测定长春西汀葡萄糖注射液有关物质及含量。方法: 采用RP-HPLC法色谱柱C18（4.6mm×250mm，5μm），以乙腈-0.2mol·L-1醋酸铵溶液(60:40)为流动相，流1.0mL·min-1，检测波长280nm，柱温30℃，进样量20μL。结果: 在选定的色谱条件下，主成及有关物质能完全分离，长春西汀在0.0107～0.0305mg·mL-1范围内浓度与峰面积的线性关系良好(r=0.999 7)，平均回收率为99.7%，RSD为0.6%(n=9)，检测限为0.071μg·mL-1。结论: 该法专属性强，准确度高，可用于长春西汀葡萄糖注射液有关物质含量的测定。 含量Determination of Related Substances and Content of Vinpocetine for Vinpocetine and Glucose Injection Yuan Lijie, Chen Jie, Yang Benxia ， Zheng Zidong (Henan Institute for Food and Drug Control, Zhengzhou 450003) Abstract Objective：To develop a RP-HPLC method for the determination of related substances and content inpocetine and glucose injection. Methods： C18 column (4.6mm×250mm5μm) was used with a mobile phase of acetonitrile-0.2mol·L-1ammonium acetate solution (60:40). The flow rate was 1.0mL·min-1, the detection wavelength was 280nm, the column temperature was 30℃ and the volume of injection was 20μL. Results：Related substances were completely separated from the main constituent. Relative response factors in the range of 0.9-1.1 between the known impurities and vinpocetine. A good linear relation of vinpocetine was observed within the range of 0.0107-0.0305mg·mL-1(r=0.999 7). The average recovery was 99.7% with RSD of 0.6 %( n=9). The detection limit of vinpocetine was 0.071μg·mL-1. Conclusion：The method of precision and specificity can satisfy the rquirements. It can be used for the control of related substances and content of vinpocetine for Vinpocetine and Glucose Injection.- 作者简介：袁利杰，女，硕士，主管药师；研究方向：从事化学药品分析及质量标准的研究Email:yuanlij@126.com Key Words：inpocetine and glucose injection；RP-HPLC；elated substances；content 长春西汀（Vinpocetine）是吲哚类生物碱长春胺的衍生物，是一种脑循环代谢改善剂，[1-2]。目前有文献报道采用HPLC对不同制剂的长春西汀有关物质进行测定 []。在检验工作中，我们发现长春西汀葡萄糖注射液本实验长春西汀葡萄糖注射液1 仪器试药 美国Agilent1100高效液相色谱仪；长春西汀对照品（批号AET080705，纯度100%）、长春胺乙酯（杂质）对照品（批号VET050705纯度100%）、阿朴长春胺（杂质）对照品（批号AVM050705纯度100%）、甲氧基长春西汀（杂质）对照品（批号MTX250210纯度100%）；二氢长春西汀（杂质）对照品（批号MTX250210