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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 technique for rapid determination of levocarnitine in levocarnitine injection by microfluidic chip non-contact conductivity detection. Methods: The microcapsule was used as the separation channel, and the high-voltage electric field was used as the driving force to realize the rapid and efficient separation of L-carnitine. The non-contact conductivity detector was used for on-line detection. The types and concentrations of buffer solutions, additives, And injection time and other factors. RESULTS: 10 mmol·L-1 MES-10 mmol·L-1 L-histidine (p-H 6) was optimized and selected as the buffer solution. The voltage of 2.00 k The linear range was 10-150 μg · mL -1 (r = 0.990 2). The detection limit (S / N = 3) was 3.0μg · m L-1, the spiked recoveries ranged from 95.5% to 99.4%. The contents of levocarnitine in three batches of samples were 98.3%, 101.2% and 101.4% respectively. Conclusion: This method is validated by methodology for the determination of levocarnitine.