复方利多卡因乳膏质控方法研究

摘要

OBJECTIVE： To develop a HPLC method for the determination of the contents of lidocaine and prilocaine in compound lidocaine cream as a quality control means.METHODS： Lidocaine and prilocaine in compound lidocaine cream were determined by high-performance liquid chromatography on C18 column with the detection wavelength at 254nm.The mobile phase was 0.5％ ammonium dihydrogen phosphate(pH=7)-methanol(20∶ 80).RESULTS： The calibration curves of both lidocaine and prilocaine were linear within the concentration range of 130～250μ g/ml(r=0.9 996).The recovery rates of lidocaine and prilocaine were 99.05％ and 99.27％ respectively， RSDs were 0.67％ and 1.15％ ， intra-day RSDs 0.81％ and 1.45％ ， inter-day RSDs 0.55％ and 0.63％ respectively.CONCLUSION： The method was sensitive， stable and accurate.It can be used to determine and control the quality of compound lidocaine cream.%目的：探讨复方利多卡因乳膏 HPLC质量控制方法，为该药的质量控制提供依据。方法：样品经处理后，在 C18柱上，以 0.5％磷酸二氢铵缓冲液（pH=7）-甲醇（20∶ 80）为流动相进行测定。结果：利多卡因和丙胺卡因在 130～250μ g/ml范围内呈现良好的线性关系， r均为 0.9 996。利多卡因和丙胺卡因回收率分别为 99.05％和 99.27％， RSD分别为 0.67％和 1.15％。溶液稳定，日内及日间 RSD为：利多卡因： 0.81％、 0.55％；丙胺卡因： 1.45％、 0.63％。方法精密可靠。结论：本方法准确、可靠，可用于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。