复方利多卡因乳膏质控方法研究

Study on Quality Control Method 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130～250μg/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。

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 lid_ocaine and prilocaine were linear within the concentration range of 130～250μg/ml(r=0 9 996) The recovery rates of lidoca_ine 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