HPLC法测定芬戈莫德胶囊的含量

Determination of contents of fingolimod in fingolimod capsules by HPLC

目的建立HPLC芬戈莫德胶囊含量测定方法。方法采用高效液相色谱法测定芬戈莫德胶囊中芬戈莫德的含量。选用色谱柱为Agilent TC-C18,流动相为高氯酸钠溶液（0.1 mol/L高氯酸钠水溶液,高氯酸调节pH值为2.8）∶甲醇∶乙腈（93∶7∶100）;检测波长215 nm,流速1.5 ml/min;进样量10μl。结果芬戈莫德浓度线性范围为0.0499～0.1499 mg/ml（r=0.9998）;样品平均回收率为100.01%（RSD=0.46%,n=3）。结论本法操作简便,重现性好,准确性高,可用于芬戈莫德胶囊的含量测定质量控制。

Objective To establish a method for determining the contents of fingolimod in fingolimod capsules by High Performance Liquid Chromatography（HPLC）.Methods HPLC was used to determine the contents of fingolimod in fingolimod capsules.The selected column was Agilent TC-C18,and the mobile phase was sodium perchlorate solution（0.1 mol /L aqueous solution of sodium perchlorate,and the pH value of perchloric acid had been adjusted to 2.8） ∶methanol ∶acetonitrile（93∶7∶100）;the detection wavelength was 215 nm with a flow rate of 1.5 ml /min;the sample size is 10 μl.Results The linear range of concentration of fingolimod was 0.0499 ～ 0.1499 mg /ml（r = 0.9998）;the average recovery rate of samples was 100.01%（RSD = 0.46%,n = 3）.Conclusion This method is simple with high reproducibility and high accuracy,and can be used to determine the contents of fingolimod in fingolimod capsules for quality control.