目的：探讨复方利多卡因乳膏质量控制方法，为该药的质量控制提供依据。方法：采用高效液相色谱法。结果：丙胺卡因在133～240 mg·L^-1、利多卡因在140～250 mg·L^-1范围内呈现良好的线性关系，r均为0.9996。样品回收率高，丙胺卡因和利多卡因回收率分别为99.27%和99.05%, RSD分别为1.14%和0.67%。样品溶液稳定，3 d内日间差异性试验结果：丙胺卡因RSD=0.73%；利多卡因RSD=0.65%。本实验方法重复性好，RSD分别为丙胺卡因1.30%，利多卡因0.91%。对3批样品进行含量测定，结果分别为:丙胺卡因99.69%，100.53%，101.86%。；利多卡因99.67%，98.30%，99.97%。结论：本方法准确，可靠，能同时测定复方利多卡因乳膏中利多卡因、丙胺卡因的含量，在本研究基础上制定的质量标准可以控制本品的质量，方法具有可行性。

OBJECTIVE To develop a method for the measurement of lidocaine and prilocaine in compound cream. METHODS lidocaine and prilocaine in complex lidocaine cream was determined by high-performance liquid chromatography with the detection wavelength at 254 nm. The mobile phase was 0.5% phosphate(pH=7)∶methanol(20∶80).RESULTS The calibration curve was linear within the range of 133～240 μg·mL^-1 for prilocaine and 140～250 μg·mL^-1 for lidocaine. The recovery of prilocaine and lidocaine was 99.27% and 99.05%,RSD was 1.14% and 0.67% respectively。The sample solution was stable, inter-day RSD of prilocaine and lidocaine was 0.73% and 0.65% respectively. The content of prilocaine and lidocaine measured in 3 batch samples were 99.69%, 100.53%, 101.86% and 99.67%, 98.30%, 99.97%. CONCLUSIONS The method was sensitive and reliable. It can be used for the quality control of the cream.