高效液相色谱法测定氟曲马唑乳膏中氟曲马唑的含量

Content determination of Flutrimazole in Flutrimazole Cream by HPLC

目的:建立高效、准确的氟曲马唑乳膏中氟曲马唑含量的高效液相色谱法。方法:采用高效液相色谱法,外标法定量。色谱条件:采用Aglient Eclipse XDB-C18(4.6×150mm,5μm)色谱柱,以乙腈-0.03mol·L^(-1)磷酸二氢钠溶液(70:30)为流动相,流速1.0m L·min^(-1),柱温40℃,检测波长:220nm。结果:氟曲马唑浓度在20.03μg·m L^(-1)~400.56μg·m L^(-1)的范围内,呈良好的线性关系,相关系数为0.9998;平均回收率(n=9为99.81%),供试品溶液在24h内稳定。结论:该方法简便、稳定、可靠,可用于测定氟曲马唑乳膏中的氟曲马唑的含量,为其质量控制提供保证。

Objective： To eatalish an HPLC method for determination of Flutrimazole in Flutrimazole Cream.Methods： Use HPLC method. The contents were calculated by external standard method. Chromatographic conditions were as follow ： the analysis was achieved using a Aglient C 18 column （4.6×150mm,5μm）with the mobile phase consisted of acetonitrile- 0.03mol. L-1 sodium dihydrogen phosphate （70： 30） pumped at a flow rate of 1.0ml. min-l.The detection was carried out at 220nm and a column temperature of 40℃ .Results： The method showed a good linear relationship within the range of 20.03μg. ml-1- 400.561xg. ml-1 （r=0.9998）, the average recoveries （n=9） were 99.81% .The sample solution was stable within 24h.Conelusion： The established method is simple , accurate and sensitive , which can be used for the determination of the Flutrimazole in Flutrimazole Cream and is helpful for quality control.