高效液相色谱法测定吡美莫司滴眼液的含量

Determination of pimecrolimus in eye drops by HPLC

目的:建立测定吡美莫司滴眼液含量的高效液相色谱方法。方法:采用Diamonsil C18(250 mm×4.6 mm,5μm)色谱柱;流动相为甲醇-0.02 mol.L-1乙酸铵溶液(82∶18);流速为1.2 mL.min-1;检测波长为210 nm;柱温为55℃。结果:吡美莫司在20～80μg.mL-1浓度范围内线性关系良好(r=0.999 8),平均回收率为100.49%,RSD为1.06%,方法重复性的RSD为1.38%(n=6)。结论:本方法专属性强、操作简便、结果准确,可用于测定吡美莫司滴眼液的含量。

Objective： To establish an HPLC method for the determination of pimecrolimus in eye drops.Methods： The separation was performed on Diamonsil C18（250 mm×4.6 mm,5 μm）,the mobile phase was methanol-0.02 mol·L^-1 aqueous ammonium acetate（82∶18） with the flow rate of 1.2 mL·min^-1,the detection wavelength was at 210 nm and column temperature was 55 ℃.Results： The calibration curve of pimecrolimus was linear within the concentration range of 20～80 μg·mL^-1,r=0.999 8.The average recovery rate of pimecrolimus was 100.49%（RSD=1.06%）,and the RSD of the repeatability test was 1.38%（n=6）.Conclusion： The method is simple,quick and specific.It can be used to determine the content of pimecrolimus in eye drops.