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文章摘要
XIA Hong-ying.Study on Improved Method for Determining the Related Substances of Ligustrazine Phosphate Pills[J].中国药物评价,2019,36(4):252-257
磷酸川芎嗪滴丸有关物质测定方法的改进研究
Study on Improved Method for Determining the Related Substances of Ligustrazine Phosphate Pills
投稿时间:2019-05-12  修订日期:2019-05-24
DOI:
中文关键词: 磷酸川芎嗪  磷酸川芎嗪滴丸  有关物质  高效液相色谱法
英文关键词: Tetramethylpyrazine phosphate  Ligustrazine phosphate pills  Related substances  High performance liquid chromatography(HPLC)
基金项目:国家药品标准提高研究项目(食药监药化管便函[2015] 1057号);江西省食品药品监督管理局科研项目(No.2016YP19)
作者单位E-mail
夏红英 江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心 xiahongying712@163.com 
钟振华 江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心  
涂明珠 江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心  
郭艳芳 江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心  
熊欣 江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心  
程奇珍 江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心 cqz1110@sina.com 
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中文摘要:
      目的:改进高效液相色谱法测定磷酸川芎嗪滴丸中的有关物质,为修订现行国家药品标准中的有关物质测定方法提供参考和依据。方法:采用RP-HPLC法,色谱柱为SHISEIDO CAPCELL PAK C18(4.6 mm×250 mm,5μm),改进后的流动相为甲醇-水(35∶65,V/V),流速为1.0 mL·min-1,检测波长为295 nm,柱温为30 ℃,进样量为20μL。结果:各杂质与主成分分离良好;磷酸川芎嗪检测质量浓度线性范围为0.312 4~12.50 μg·mL-1(r=0.999 9);定量限为6.249 ng,检测限为2.083 ng;精密度、稳定性、重复性试验的RSD<1.0%。结论:改进后的方法更加合理、准确、专属,可用于测定磷酸川芎嗪滴丸中的有关物质。
英文摘要:
      Objective:To improve the HPLC method for determining the related substances of Ligustrazine phosphate pills, which provides reference and basis for revising the determination method of related substances in current national drug standard. Methods:RP-HPLC was performed on the column of SHISEIDO CAPCELL PAK C18(4.6 mm×250 mm, 5μm),the modified mobile phase was methanol-water(35∶65,V/V)with a flow rate of 1.0 mL·min-1,detection wavelength was performed at 295 nm,column temperature was 30 ℃, and the injection volume was 20 μL. Results:The impurity peaks were well separated from the principal component peak,the linear range of Ligustrazine phosphate concentration was 0.312 4-12.50 μg·mL-1(r=0.999 9);limit of quantitation was 6.249 ng,and limit of detection was 2.083 ng. RSDs of precision,stability and repeatability tests were all less than 1.0%. Conclusion:The improved method is more reasonable, accurate and specific, which can be used to determinate the related substances of Ligustrazine phosphate pills.
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