HPLC法测定双氯芬酸钠盐酸利多卡因注射液的有关物质

Determination of Diclofenac sodium and Lidocaine Hydrochloride Injection related substances by HPLC

目的:建立HPLC法测定复方制剂双氯芬酸钠盐酸利多卡因注射液中的有关物质。方法:采用反相高效液相色谱法,以自身对照法计算双氯芬酸钠盐酸利多卡因注射液有关物质的量。用C18(250mm×4.6mm,5μm)色谱柱,以甲醇-4%冰醋酸溶液(65∶35)为流动相,流速1.0m L/min,于波长为245nm处检测。结果:双氯芬酸钠与利多卡因杂质完全分离,有关物质的线性回归方程为A=22.139×C+2.3422,相关系数为r=0.9995(n=5);方法的最低检出限为0.0089%。结论:实验证明该法简便快捷,能准确地测定样品的有关物质。

Objective：To establish a HPLC method for the determination of Diclofenac sodium and Lidocaine Hydrochloride Injection related substances. Methods：The sample was analyzed on a C18（250mm×4.6mm,5μm）column with mobile phase consisting of methonal-4% Acetic Acid（65∶35）. The flow rate was 1.0m L/min and the detection wavelength was 245 nm. Results：The peaks of Diclofenac,Lidocaine and its impurities were completely separated. The regression equation for related substances was A =22.139 ×C ＋2.3422,r =0.9995（n=5）. The detection limit was 0.0089%. Conclusions：This method is convenient,quick and reproducible for the quantitative determination of Diclofenac sodium and Lidocaine Hydrochloride Injection in the related substances.