微流控芯片非接触电导法测定左卡尼汀注射液的含量

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^-1 L-组氨酸(L-His)(pH 6)为缓冲溶液,分离电压2.00 kV、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10~150 μg·mL^-1(r=0.990 2),检出限(S/N=3)为3.0 μg·mL^-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^-1 MES－10 mmol·L^-1 L-His (pH 6)as the buffer solution at the separation voltage of 2.00 kV 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·mL^-1 to 150 μg·mL^-1,the linear equation was Y=17.08X+610.6 with a correlative coefficient of 0.990 2,the limit of detection reached 3.0 μg·mL^-1 (S/N=3),and the recoveries were 95.5%-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.

[1] HUANG XY(黄秀玉).Clinical observation of L-carnitine in treatment of unstable angina pectoris(左卡尼汀治疗不稳定型心绞痛的临床观察)[J].Chin J Mod Drug Appl(中国现代药物应用),2013,7(22):104
[2] WANG X(王旭),MENG XP(孟晓萍).L-carnitine treatment in patients with chronicheart failure is effective and its correlation with dose(左卡尼汀治疗慢性心力衰竭患者的有效性及其与剂量相关性)[J].Chin J Gerontol(中国老年学杂志),2014,34:517
[3] FULLER RK,HOPPEL CL.Elevanted plasma carnitine in hepatic cirrhosis[J].Hepatology,1983,3(4):554
[4] GAO LJ(高立军),WANG T(王涛),QUAN DQ(全东琴).An HPLC-method of determination of content of levocarnitine injection(高效液相色谱法测定左卡尼汀注射液的含量)[J].Sci Technol Eng(科学技术与工程),2011,11(30):7494
[5] Drug Standards of China.New Medicine Transfer Standard.Vol 61(中国药品标准
[6] JX20060188 The Imported Drug Registration Standards(进口药品注册标准)[S].2006
[7] LING BC(林炳承).Microfulid-based lab-on-a-chip and its functionality(微流控芯片实验室及其功能化)[J].J China Pharm Univ(中国药科大学学报),2003,34(1):1
[8] GUO MX(郭明星),ZHAO BS(赵保胜),GAO XY(高晓燕).Research progress and prospect of microfluidics in medical field(微流控技术在医药领域的研究进展)[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2012,18(18):323
[9] YANG XJ(杨秀娟),LI OL(李偶连),CHEN ZG(陈缵光),et al.Determination of pseudoephedrine hydrochloride and dextromethorphan hydrobromidein cold tablet by micro-fluidic chip(微流控芯片非接触电导法测定感冒药中盐酸伪麻黄碱和氢溴酸右美沙芬)[J].Chin J Anal Chem(分析化学),2008,36(5):673
[10] CAI ZY(蔡自由),LI YC(李永冲),CHEN ZG(陈缵光).Determination of moroxydine hydrochloride tablets by microfluidic chip(微流控芯片测定盐酸吗啉胍片含量)[J].Chin J Pharm Anal(药物分析杂志).2011,31(8):1492
[11] SONG ZR,XU Y,CHEN ZG,et al.Quantification of lactate in synovia by microchip with contactless conductivity detection[J].Anal Biochem,2013,434(1):73
[12] CHEN ZG(陈缵光),WANG LS(王立世),MO JY(莫金垣).Development of micro total analysis system for micro power(微全分析系统专用微型电源的研制)[J].Chem J Chin Univ(高等学校化学学报),2004,25(Suppl):24
[13] CHEN ZG,LI QW,LI QL,et al.A thin cover glass chip for contactless conductivity detection in microchip capillary electrophoresis[J].Talanta,2007,71(5):1944