微流控芯片非接触电导法测定左卡尼汀注射液的含量  

Determination of levocarnitine injection by microfluidic chip with contactless conductivity

作　　者：肖羽[1,2] 张琳 施亦斌[1] 陈缵光[2] 

机构地区：[1]广州市药品检验所,广州510160 [2]中山大学药学院,广州510006

出　　处：《药物分析杂志》2015年第4期728-731,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家自然科学基金(Nos.21075139;21375152)资助

摘　　要：目的：建立以微流控芯片非接触电导检测法快速测定左卡尼汀注射液中左卡尼汀含量的新技术。方法：以芯片毛细管为分离通道,以高压电场为驱动力实现左卡尼汀的高效快速分离,配以非接触电导检测器进行在线检测;探讨并优化缓冲溶液的种类和浓度、添加剂、分离电压和进样时间等因素。结果：优化并选择了10 mmol·L^-1水吗啉乙磺酸（MES）-10 mmol·L^-1L-组氨酸（L-His）（p H 6）为缓冲溶液,分离电压2.00 k V、进样时间10 s,1 min内可实现左卡尼汀的快速测定;线性范围为10~150μg·m L^-1（r=0.990 2）,检出限（S/N=3）为3.0μg·m L^-1,加标回收率为95.5%~99.4%;3批样品中左卡尼汀含量分别为98.3%、101.2%、101.4%。结论：该方法经方法学验证适用于左卡尼汀的含量测定。Objective： To establish a new and simple method for the rapid determination of levocarnitine in levocarnitine injection by method of microfluidic chip with contactless conductivity. Methods： Levocarnitine was rapidly separated by microfluidic chip under high electric field and detected with contactless conductivity detector. The electrophoretic parameters,such as the variety and concentration of buffer solution and additive,the separation voltage and the injection time,etc.,were investigated and optimized. Results： In optimal conductions,using 10 mmol·L^-1MES^-10 mmol·L^-1L- His（ pH 6） as the buffer solution at the separation voltage of 2. 00 k V and the injection time of 10 s,levocarnitine was separated and detected within 1 min. The linear respondence of the concentration of levocarnitine ranged from 10 μg·m L^-1to 150 μg·m L^-1,the linear equation was Y = 17. 08 X ＋ 610. 6 with a correlative coefficient of 0. 9902,the limit of detection reached 3. 0 μg·m L^-1（ S /N = 3）,and the recoveries were95. 5%- 99. 4%. The contents of levocarnitine in 3 batches of samples were 98. 3%,101. 2%,and 101. 4%. Conclusion： It is proved that the method could be used for rapid determination of levocarnitine with satisfactory results.

关 键 词：左卡尼汀 左肉毒碱 氨基酸药物 微流控芯片技术 非接触电导检测 快速含量测定 方法学验证 

分 类 号：R917[医药卫生—药物分析学]