复方利多卡因乳膏质控方法研究

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130～250μg/ml范围内呈现良好的线性关系 ,r均为0 9996。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。

Study on Quality ControlMethod of Compound Lidocaine Cream

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.