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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 13 3～ 2 40mg·L- 1、利多卡因在 14 0～ 2 50mg·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 99.2 7%和 99.0 5% ,RSD分别为 1.14 %和 0 .67%。样品溶液稳定 ,3d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 1.3 0 % ,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 99.6 9% ,10 0 .53 % ,10 1.86 %。;利多卡因 99.6 7% ,98.3 0 % ,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 explore the quality control method of compound lidocaine cream and provide basis for its quality control. Methods: Using high performance liquid chromatography. Results: Prismocaine showed good linearity in the range of 140 ~ 240 mg · L -1 and lidocaine in the range of 140 ~ 250 mg · L -1, all of which were 0.9996. The recovery rate of samples was high, the recoveries of prilocaine and lidocaine were 99.2 7% and 99.0 5%, respectively, and the RSDs were 1.14% and 0.67% respectively. The sample solution was stable. The results of day-to-day variability in 3 days showed that RSD was 0.73% for prilocaine and 0.65% for lidocaine. The reproducibility of this method is good, RSD were 1.3% of prilocaine, 0.91% of lidocaine. Three batches of samples were determined, the results were: prilocaine 99.6 9%, 10 0 .53%, 10 1.86%. ; Lidocaine 99.6 7%, 98.3 0%, 99.97%. Conclusion: The method is accurate and reliable. The method can simultaneously determine the contents of lidocaine and prilocaine in compound lidocaine cream. The quality standards of the compound can be controlled on the basis of the study. The method is feasible.