盐酸芬戈莫德含量测定方法研究

Content determination method research of fingolimod hydrochloride

文章建立了HPLC法测定盐酸芬戈莫德原料药含量的方法。试验结果表明:盐酸芬戈莫德在0.055 0~0.165 0 mg/ml范围内呈良好的线性关系,Y=158 490 160X-51 837.4,r^2=0.999 8;精密度RSD为0.11%,表明仪器精密度良好;重复性RSD为0.09%,表明含量测定重复性良好;稳定性RSD为0.13%,表明供试品溶液至少在12 h内稳定;加样回收率RSD为1.37%,表明此方法可行;样品耐受性良好。由以上数据显示测定结果准确、可靠,表明所建立的HPLC法能有效的控制本品的质量。

This paper established a method for determining the content of fingolimod hydrochloride drug substance by HPLC. HPLC method for the determination of test results showed that： fingolimod hydro- chloride in the range of 0.055 0-0.165 0 mg/ml good linear regression equation was Y=158 490 160X- 51 837.4, r2=0.999 8; precision RSD was 0.11%, indicating that the instrument good precision; repeat- ability RSD 0.09%, indicating good reproducibility determination; stability RSD was 0.13%, indicating that the test solution at least stable within 12 h; recoveries and RSD was 1.37%, indicating that this method is feasible; sample well tolerated. From the above data display measurement results are accu- rate, reliable, and show that the established HPLC method can effectively control the quality of the product.