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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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离子色谱法测定盐酸法舒地尔药物中高哌嗪含量

Determination of homopiperazine in fasudil hydrochloride by ion chromatography

分类号:
出版年·卷·期(页码):2013,33 (6):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 建立高效离子色谱法测定药物盐酸法舒地尔中高哌嗪含量的方法。 方法: 采用阳离子色谱柱IonPac CS17(4 mm×250 mm),以17 mmol·L-1甲烷磺酸溶液-乙腈(85∶15)作为淋洗液,进样量25 μL,在流速1.0 mL·min-1的条件下,测定盐酸法舒地尔样品中残留药物中间体高哌嗪的含量。 结果: 在0.05~10 μg·mL-1范围内线性关系良好,线性相关系数为0.9996,加样回收率在97.8%~101.2%之间。 结论: 该方法具有灵敏度高,操作简单,重复性好等特点,能够快速准确测定药物中的痕量高哌嗪。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish a new method for the determination of homopiperazine in fasudil hydrochloride based on high-performance ion chromatography. Methods: Fasudil hydrochloride was first dissolved in methane sulfonic acid, and then the solution was filtered through a 0.45 μm syringe membrane filter and Guard RP cleanup column before injection. The IC separation was performed on an IonPac CS17 (4 mm×250 mm) column with 17 mmol·L-1 methanesulfonic acid and acetonitrile(85∶15)as the elution and a Cation MicroMembrane Suppressor(CMMS 300,4 mm)as the suppression. Results: The background was much reduced and the sensitivities of homopiperazine were greatly improved.Calibration curves of peak area versus concentration showed a linear correlation coefficient of 0.9996 for homopiperazine in the range of 0.05-10 μg·mL-1.Average recoveries were between 98.0%-102.0%. Conclusion: The established Ion chromatography method has the advantages of high sensitivity,specificity and reproductivity, which can be applied to the limit amount determination of drug homopiperazine.

-----参考文献:---------------------------------------------------------------------------------------
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4 WANG Dao-ling(王道林),QIAN Jian-hua(钱建华),LIU Ling(刘琳),et al.Novel synthesis method for homopiperazine(高哌嗪的新合成法).Chem Reagents(化学试剂),2006,28(5):311
5 DING Quan(丁泉).Determination of residual solvents in fasudil hydrochloride by headspace gas chromatography(顶空气相色谱法测定盐酸法舒地尔中有机溶剂残留量).Fujian Anal Test(福建分析测试),2011,20(2):31
6 LI Qi-lu(李其禄), YANG Dong-xia(杨冬霞),WANG Xian-lei(王宪磊),et al.Determination of residual solvent in fasudil hydrochloride by head-space gas chromatography(盐酸法舒地尔残留溶剂检查的方法学研究).Qilu Pharm Aff(齐鲁药事),2011,30(2):96
7 MA Li (马丽),YAO Tong-wei(姚彤炜).Determination of residual solvents in fasudil hydrochloride by headspace GC(顶空GC测定盐酸法舒地尔中残留溶剂).Chin J Mod App Pharm(中国现代应用药学),2010,27(12):1121
8 WENG Yi-ling(翁一玲),LI Ming(李鸣),CHEN Song-wang(陈松旺).The study on bacterial endotoxin test of fasudil hydrochloride injection(盐酸法舒地尔注射液细菌内毒素检查法建立及方法学研究).Strait Pharm J(海峡药学),2012,28(4):57
9 GE Xin(葛欣),MENG Xiang-jun(孟祥军),LI Na-ran(李娜然).Determination of related substances in fasudil hydrochloride by HPLC (HPLC测定盐酸法舒地尔的有关物质).Chin J Spectros Lab(光谱实验室),2011,(28)4:1908
10 Chen HY,Lin Y,Han M.Simultaneous quantitative analysis of fasudil and its active metabolite in human plasma by liquid chromatography electrospray tandem mass spectrometry.J Pharm Biomed Anal,2010,52(2):242
11 LI Jin-tao (李金涛),GAN Wei(干伟),DENG Yuan-yuan(邓媛媛),et al.Determination of fasudil hydrochloride by HPLC(HPLC法测定盐酸法舒地尔的含量).China Pharm(中国药师),2010(11):1609
12 Lü Jie(吕洁),MENG Xiang-jun(孟祥军),ZOU Chun-yang(邹春阳).Fasudil hydroehloride content in fasudil hydroehloride injection with ultraviolet-visible spectrophotometry(紫外-可见分光光度法测定盐酸法舒地尔注射液中盐酸法舒地尔的含量).Qilu Pharm Aff(齐鲁药事),2011,30(2):96

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