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高效液相色谱法测定石杉碱甲片的含量及其有关物质

来源:中国色谱网
摘要:NewPage1摘要:目的:采用高效液相色谱法测定石杉碱甲片的含量、含量均匀度以及有关物质。关键词:高效液相色谱法石杉碱甲片含量含量均匀度有关物质分类号:R927文献标识码:AAssayofContentofHuperzine-ATablets,TestsforUnifor......

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摘 要:目的:采用高效液相色谱法测定石杉碱甲片的含量、含量均匀度以及有关物质。方法:采用ODS-C18柱,以pH3.2磷酸三乙胺缓冲液-水(50∶50)为流动相,流速1mL.min-1,用紫外检测器于307nm波长处检测。结果:石杉碱甲在浓度为12.8~159.3μg.mL-1范围内,浓度与其峰面积呈良好的线性关系(r=0.99996)。平均回收率为100.3%,RSD=0.44%(n=21)。检出的最低量为石杉碱甲6ng。结论:较原试行标准简便,准确。


关键词:高效液相色谱法 石杉碱甲片 含量 含量均匀度 有关物质


分类号:R927 文献标识码:A

Assay of Content of Huperzine-A Tablets,Tests for Uniformity of Content and Its Related Substances by HPLC

WANG Guo-fengHenan Drug Control Institute,Zhengzhou 450003) 
ZENG FangHenan Drug Control Institute,Zhengzhou 450003) 
ZHENG Zi-dongHenan Drug Control Institute,Zhengzhou 450003) 

AbstractObjectiveTo establish a HPLC method for the assay of the content of huperzine-A tablets,the uniformity of content and its related substances.Method:Using ODS-C18 column,the mixture of buffer solution of phosphoric acid-triethylamine(pH 3.2)and water(5050)as mobile phase,at a flow rate of 1 mL.min-1,wavelength of the detector was 307 nm.Results:There is a good linear relationship within the range of 12.8159.32 μg.mL-1(r=0.999 96).The average recovery is 100.3%RSD is 0.44%(n=21).The lowest limit of detection is 6 ng.Conclusion:The new method is more rapid,simple and accurate than the old one.


Keywords
HPLC,huperzine-A tablets,content,uniformity of content,related substances

 

作者单位:王国峰(河南省药品检验所化学室郑州 450003) 
     曾芳(河南省药品检验所化学室郑州 450003) 
     郑子栋(河南省药品检验所化学室郑州 450003) 

参考文献:

[1]WANG Yue-e(王月娥),YUE Dong-xian(岳冬贤),TANG Xi-can(唐希灿),et al. Anti-cholinesterase activity of huperzine A(石杉碱甲的抗胆碱酯酶作用).Acta Pharmacol Sin(中国药理学报),1986,7(2):110(in Chinese)
[2]Hanin I.Clinical and preclinical studies with huperzine.Cholinergic Basis of Alzheimer Therapy.Boston:Birkhauser,1991.305
[3]ZHANG Rui-wu(张锐武),TANG Xi-can(唐希灿),HAN Yan-yi(韩燕艺),et al.Drug-evaluation of huperzine A in the treatment of senile memory disorders(石杉碱甲治疗老年期记忆障碍的药物评价).Acta Pharmacol Sin(中国药理学报),1991,12(3):250(in Chinese)
[4]Drug Specifications Promulgated by the Ministry of Public Health,P R China(Trial)[卫生部药品标准(试行)].WS-127(X-107)-94
[5]ChP(中国药典).2000.Vol Ⅱ(二部):Appendix(附录)ⅩⅤD
[6]The National Pharmacopoeia Committee(国家药典委员会).The Handbook of National Pharmaceutic Quality Standard(3th ed)[国家药品标准工作手册(第三版)].1998.138
[7]The Pharmaceutic Quality Standard of Zhejiang Province(浙江省药品标准).1993.364
[8]ZHU Wei-liang(朱维良),JIANG Hua-liang(蒋化良),CHEN Jian-zhong(陈建忠),et al.QSAR study on huperzine A analogs with quantum chemistry parameters using the DLS method(石杉碱甲类化合物定量构效关系的量子化学研究).Chin J Med Chem(中国药物化学杂志),1997,7(4):258(in Chinese)

收稿日期:2000年11月24日

出版日期:2001年3月31日

原载于《药物分析杂志》2001 Vol.21  No.2   P.85-88

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作者: 王国峰 曾芳 郑子栋 2007-5-18
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