离子色谱法测定盐酸法舒地尔注射液中的高哌嗪  

Determination of homopiperazine in Fasudil Hydrochloride Injection by ion chromatographic

作　　者：沈艳丽 刘建平 

机构地区：[1]鲁南制药集团股份有限公司国家手性制药工程技术研究中心,山东临沂276006

出　　处：《药学研究》2015年第10期581-583,共3页Journal of Pharmaceutical Research

摘　　要：目的建立盐酸法舒地尔注射液中高哌嗪含量的离子色谱检测方法.方法采用IonPacCS12A（4mm×250mm）阳离子交换色谱柱;以20mmol·L^-1甲磺酸水溶液-乙腈（80∶20）为淋洗液,流速为1.0mL·min^-1;外接抑制器,以100mmol·L^-1四丁基氢氧化铵水溶液为再生液;进样量为50μL,检测器温度为30℃.结果高哌嗪在0.30～7.56μg·mL^-1浓度范围内线性关系良好（r=0.9997）,平均回收率为99.99%.结论该法灵敏度高、专属性强、重现性好,可用于盐酸法舒地尔注射液中高哌嗪的含量测定.Objective To establish an ion chromatographic method for the determination of homopiperazine in Fasudil Hydrochloride Injection. Methods The samples were analyzed on the Ion Pac CS12A( 4 mm × 250 mm) exchange column,and connected the external suppressor,the mobile phase was 20 mmol·L- 1mesilate in water- acetonitrile( 80∶20),the regen liquid was 100 mmol·L- 1tetrabutyl ammonium hydroxide in water,the flow rate was 1. 0 m L·min- 1,the injection volumn was 50 μL and the detector temperature was 30 ℃. Results The linear range of homopiperazine was 0. 30 ~ 7. 56μg·m L- 1,r = 0. 999 7,The average recovery was 99. 99%. Conclusion The established method was senstitive,specific,repeatable and suitable for the determination of homopiperazine in Fasudil Hydrochloride Injection.

关 键 词：离子色谱 抑制器 盐酸法舒地尔注射液 高哌嗪 

分 类 号：R927.11[医药卫生—药学]