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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 explore HPLC quality control method of compound lidocaine cream, and to provide basis for its quality control. Methods: After the sample was processed, it was determined on a C18 column with 0 5% ammonium dihydrogen phosphate buffer (pH = 7) -methanol (20:80) as the mobile phase. Results: There was a good linear relationship between lidocaine and prilocaine in the range of 130 ~ 250μg / ml, r = 0 9996. The recoveries of lidocaine and prilocaine were 99 05% and 99 27%, respectively, with RSDs of 0 67% and 15%, respectively. The solution was stable with RSD of day and day: lidocaine: 0 81%, 0 55%; prilocaine: 1 45%, 0 63%. The method is precise and reliable Conclusion: This method is accurate and reliable. It can be used to determine the content of lidocaine and prilocaine in compound lidocaine cream. The quality standard can control the quality of the product based on the research. The method is feasible.