高效液相色谱法测定复方利多卡因乳膏中利多卡因和丙胺卡因的含量分析  

Simultaneous Content Determination of Lidocaine and Prilocaine in Compound Lidocaine Cream by High Performance Liquid Chromatography

作　　者：查元 马丽 王璐璐 ZHA Yuan;MA Li;WANG Lu-lu(School of Pharmacy,Anqing Medical College,Anqing,Anhui 246052,China)

机构地区：[1]安庆医药高等专科学校药学院,安徽安庆246052

出　　处：《河北北方学院学报（自然科学版）》2024年第10期1-4,36,共5页Journal of Hebei North University:Natural Science Edition

基　　金：安徽高校自然科学重点研究项目(No.2023AH053424)。

摘　　要：目的 建立高效液相色谱法(high performance liquid chromatography, HPLC)同时测定复方利多卡因乳膏中利多卡因与丙胺卡因含量的方法。方法 采用AgilentXDB C_(18)(150 mm×4.6 mm, 5μm)色谱柱,以10 mmol·L^(-1)硼砂溶液(pH 6.0)-乙腈(70∶30)为流动相,柱温30℃,检测波长210 nm,流速1.0 mL·min^(-1),进样量10μL。结果 利多卡因与丙胺卡因分离度良好,2组分在测定质量浓度0.50~0.13 mg·mL^(-1)范围内与峰面积均呈良好的线性关系(r>0.9995),平均回收率(n=9)分别为101.0%、100.2%,RSD均小于1.5%,仪器精密度、重复性及溶液稳定性试验结果均符合要求。结论 建立的HPLC法灵敏度高、重复性好、准确可靠,可同时测定复方利多卡因乳膏中利多卡因和丙胺卡因的含量。Objective To develop a high performance liquid chromatography(HPLC)method for the simultaneous determination of lidocaine and prilocaine content in compound lidocaine cream.Methods Agilent XDB C_(18)(150 mm×4.6 mm,5μm)chromatographic column was used.The mobile phase consisted of a 10 mmol·L^(-1)borax solution(pH 6.0)and acetonitrile in a ratio of 70∶30.The column temperature was set to 30℃.Detection wavelength was set at 210 nm.The flow rate was 1.0 mL·min^(-1).The injection volume was 10μL.Results Lidocaine and prilocaine had good separation and good linearity in the determination range of 0.50~0.13 mg·mL^(-1)(r>0.9995).Its average recovery rates(n=9)were 101.0%and 100.2%with RSDs all less than 1.5%.In addition,the instrument precision,repeatability and solution stability of test results met the requirements.Conclusion This proposed method has high sensitivity,good repeatability,accuracy and reliability,which can be used to simultaneously determine the content of lidocaine and compoun prilocaine in compound lidocaine cream.

关 键 词：高效液相色谱法 复方利多卡因乳膏 利多卡因 丙胺卡因 含量测定 

分 类 号：R289.1[医药卫生—方剂学]