高效液相色谱法测定环吡酮胺乳膏中药物的含量及其体外透皮释放量的研究

Research on high performance liquid chromatography method for the determination of drugs in ciclopirox olamine cream and its in vitro transdermal release quantity

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 determinate content of drugs in ciclopirox olamine cream by high performance liquid chromatography method（HPLC） and its in vitro transdermal release.MethodsDetection wavelength of 305 nm; mobile phase： acetonitrile -0.1% four acetic acid disodium ethylenediamine solution（70-30）; Kromasil C18 chromatographic column; application of single chamber Franz diffusion pool, big abdomen skin transdermal release experiments, contrasted the transdermal cream with homemade cream market results.ResultsCiclopirox olamine cream range between 20~180μg/ml, the average recovery was 99.8%, RSD was 0.70%, had good linear relationship （r=0.9997）, and related factors 0.9673, cream market and the results of the homemade cream transdermal no statistical significance（P〉0.05）.ConclusionBy high performance liquid chromatography determination of ciclopirox olamine cream won’t be affected by the composition of the skin with cream base with easy operation, high accuracy, ideal measurement effect.