建立了微流控芯片非接触电导检测法测定盐酸利多卡因注射液中盐酸利多卡因含量的方法。探讨了缓冲液种类和浓度、添加剂种类和浓度、分离电压和进样时间等因素对分离检测的影响。优化并选择1.0mmol/LHAc-2.0mmol/LNaAc(pH4.5)为缓冲溶液,1%乙醇为添加剂,分离电压为2.4kV,进样时间为10s,2min内可实现盐酸利多卡因的快速检测。在优化实验条件下,盐酸利多卡因的线性范围为20—250mg/L(r=0.996),检出限(SIN=3)可达5.0mg/L,RSD为1.7%,加标回收率为97%-99%。方法简便快速、重复性好,适用于药品生产的质量控制。
A new method was established for the determination of lidocaine hydrochloride in lidocaine hydrochloride injection by microfluidic chip with contactless conductivity detection. The effects of electrophoretic parameters, such as the type and concentration of buffer solution and additive, separation voltage and injection time, etc. on separation efficiency were investigated. In optimal condi- tions, lidocaine hydrochloride was successfully separated and detected in 2 min using 1.0 mmol/L HAc - 2. 0 mmol/L NaAc ( pH 4. 5 ) as buffer solution and 1% alcohol as additive with the separation voltage of 2. 4 kV and injection time of 10 s. The linear dependence of the concentration of lidocaine hydrochloride ranged from 20 mg/L to 250 mg/L with a correlation coefficient of 0. 996. The detection limit(S/N=3) was 5.0 mg/L. The RSD of lidocaine hydrochloride was 1.7% and the spiked recoveries ranged from 97% to 99%. The method was simple, rapid and well reproducible, and could applied for the quality control of the product.