高效液相色谱法测定维地西林涂剂中盐酸丁卡因的含量

Determination of Hydrochloride Tetracaine in Verdicyline Paint by HPLC

目的:建立维地西林涂剂中盐酸丁卡因的质量控制方法,保障安全用药。方法:采用高效液相色谱法测定,色谱柱:Diamonsil-C18柱(250 mm×4.6 mm,5μm);流动相:甲醇-0.4%三乙胺溶液(用稀磷酸调节pH值至3.0)(55∶45);流速1.0 mL/min;检测波长311 nm;进样量20μL;柱温30℃。结果:盐酸丁卡因在0.494～12.350μg/mL范围内线性关系良好,线性方程为Y=0.065X+0.0086(r=0.9995),平均回收率为99.8%,RSD=0.96%(n=6)。结论:本研究所建方法快速、简便、重现性好,适用于维地西林涂剂中盐酸丁卡因的含量测定。

Objective： To establish a quality control method of hydrochloride tetracaine in verdicyline paint to ensure the safety of patients.Methods： By using HPLC method,C18 column（250 mm×4.6 mm,5 μm） was chosen;the mobile phase was methanol-0.4% triethylamine solution（adjust pH to 3.0 with phosphoric acid）（55∶45）;the flow rate was 1.0 mL/min;the detection wave length was 311 nm;the volume of sample was 20 μL;the column temperature was set at 30 ℃.Results： The curve of hydrochloride tetracaine was linear within a range of 0.494~12.350 μg/mL;the linear equation was Y=0.065X＋0.0086（r=0.9995）;the average recovery was 99.8% with RSD of 0.96%（n=6）.Conclusions： This method is fast,convenient,and with good reproducibility.It could be used to the content determination of hydrochloride tetracaine in verdicyline paint.