环吡酮胺涂膜剂的制备及含量测定

Preparation and Determination of Ciclopirox Olamine Film by HPLC

目的:制备环吡酮胺涂膜荆,采用高效液相色谱法测定含量。方法:采用Hypersil ODS C_(18)(250mm×4.6mm,5μm)色谱柱,以0.02mol·L^(-1)磷酸二氢钠溶液-甲醇(40:60)为流动相,流速:1.0ml·min^(-1),检测波长为304nm,柱温:30℃。结果:环吡酮胺及有关物质能得到完全分离,环吡酮胺在32～192μg·ml^(-1)浓度范围内呈良好的线性关系,r=0.999 6。平均回收率为100.5%,RSD=0.9%(n=9)。结论:制备工艺简单,含量测定方法准确、可靠。

Objective： To prepare ciclopirox olamine film and determine the content by HPLC. Method： Hypersil ODS C18 column （250 mm × 4.6 mm ,5 μm） was used, the mobile phase consisted of 0.02 mol· L^-1 sodium dihydrogen phosphate solution-methanol （40： 60） ,the flow rate was 1.0 ml.min^-1 ,the detection wavelength was at 304 nm, and the column temperature was 30 ℃. Result： The method can completely separate Ciclopirox Olamine and its related substances in Ciclopirox Olamine film, and showed good linearity for Ciclopirox Olamine whthin the range of 32 - 192 μg· ml^- 1 （ r = 0. 999 6 ）, and the average recovery was 100.5% （ RSD = 0.9% ）. Conclusion： The preparation is simple, and the method is accurate and reliable.