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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 coated film and determine its content by high performance liquid chromatography. Methods: The mobile phase was Hypersil ODS C 18 (250 mm × 4.6 mm, 5 μm) with 0.02 mol·L -1 sodium dihydrogen phosphate solution (40:60) as mobile phase and the flow rate was 1.0 ml · Min ~ (-1), detection wavelength of 304nm, column temperature: 30 ℃. Results: Ciclopirox olamine and its related substances were completely separated. Ciclopirox olamine showed a good linearity in the range of 32-192 μg · ml -1, r = 0.999 6. The average recovery was 100.5%, RSD = 0.9% (n = 9). Conclusion: The preparation process is simple, the content determination method is accurate and reliable.