高效液相色谱法测定一次性神经刺激针对盐酸利多卡因注射液的吸附作用

Determination of adsorption of lidocaine hydrochloride injection by single-use nerve stimulation by HPLC

目的:探讨高效液相色谱法测定一次性神经刺激针对盐酸利多卡因注射液吸附作用的可行性,及对盐酸利多卡因注射液的吸附作用。方法:高效液相色谱法采用安捷伦C18色谱柱(5μm 4.6×150 mm),乙腈-磷酸盐缓冲液(50∶50),检测波长为254 nm,流率1.0 ml/min,柱温30℃。结果:该测定方法盐酸利多卡因的浓度在100~600μg/ml范围内线性关系良好(r=0.9993),平均回收率为94.10%[相对标准偏差(RSD)=0.75%,n=9],检测限为0.06μg/ml,定量限为0.25μg/ml。利多卡因空白对照组与初始药液浓度比为97.60%,流经一次性使用神经刺激针产品的利多卡因与初始药液浓度比为99.70%。结论:高效液相色谱法简单快速,重现性好,回收率高,精密度好,干扰少,定性定量准确。一次性使用神经刺激针对盐酸利多卡因注射液基本无吸附作用。

Objective:In this paper,HPLC was established to determine the adsorption of single-use nerve stimulation on lidocaine hydrochloride injection.Methods:HPLC was performed on Agilent C18 column(5μm 4.6×150 mm),acetonitrilephosphate buffer(50∶50),detection wavelength of 254 nm,flow rate of 1.0 ml/min,and column temperature of 30℃.Results:The concentration of lidocaine hydrochloride in this method was in a linear relationship between 100 and 600μg/ml(r=0.9993),and the average recovery rate was 94.1%(RSD=0.75%,n=9).The detection limit was 0.06μg/ml,and the quantification limit was 0.25μg/ml.The concentration ratio of lidocaine blank control group and the initial liquid medicine was 97.6%,the concentration ratio of lidocaine flowing through the disposable nerve stimulation needle product to the initial liquid medicine was 99.7%.Conclusion:The method is simple and fast,with good reproducibility,high recovery rate,good precision,less interference,accurate qualitative and quantitative,and can be used as a test method for the study of the adsorption of lidocaine hydrochloride injection by single-use nerve stimulation.