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目的探讨环吡酮胺乳膏应用高效液相色谱法进行药物含量与体外透皮释放量测定的效果。方法检测波长305 nm;流动相:乙腈-0.1%乙二胺四醋酸二钠溶液(70:30);Kromasil C18色谱柱;应用单室Franz扩散池、大鼠腹皮进行透皮释放实验,对比市面乳膏与自制乳膏的透皮结果。结果环吡酮胺范围介于20~180μg/mL间,平均回收率99.8%,RSD为0.70%,线性关系较好(r=0.9997),相关因素为0.9673,市面乳膏与自制乳膏透皮结果差异无统计学意义(P>0.05)。结论采用高效液相色谱法测定环吡酮胺乳膏不会受皮肤成分与软膏基质影响,且操作简便,准确率高,测定效果理想。
Objective To investigate the effect of ciclopirox olamine cream on determination of drug content and transdermal delivery in vitro by high performance liquid chromatography. The detection wavelength was 305 nm. The mobile phase consisted of acetonitrile-0.1% disodium EDTA (70:30) and Kromasil C18 column. Transdermal results of marketed creams and homemade creams. Results Ciclopirox olamine ranged from 20 to 180 μg / mL with an average recovery of 99.8% and a RSD of 0.70% (r = 0.9997), with a correlation of 0.9673. The difference was not statistically significant (P> 0.05). Conclusion The determination of ciclopirox olamine cream by the high performance liquid chromatography will not be affected by skin composition and ointment matrix, and the operation is simple, high accuracy, the determination of the results.