RP-HPLC法检查莫达非尼中有关物质及其片剂的含量测定

Determination of modafinil and impurities in modafinil tablets by RP-HPLC

目的 :建立用RP -HPLC法进行莫达非尼有关物质及其片剂的含量测定方法。方法 :采用ODS柱 ,以 ψ(乙腈 ∶水 ) =4∶ 6为流动相 ,流速 1mL/min ;检测波长。结果 :在选定的色谱条件下 ,有关物质与主药分离良好 ,莫达非尼在 1.661～ 4.982 μg ,即进样量为 2 0 μL时的样品 ρ =83～ 2 49μg/mL范围内 ,浓度与峰面积线性良好 ,平均回收率 10 0 .11% ,RSD =0 .3 3 %。结论 :本法可用于莫达非尼有关物质的检查及片剂的含量测定。

Objective: To establish a RP HPLC method for the determination of modafinil related substances and modafinil in modafinil tablets. Method: The samples was analysed on a ODS column with acetonitrile/water(4 ∶ 6) as mobile phase. The flow rate was 1.0 mL/min and UVdetection was at 225nm. Results:Between the concentration range from 83 to 249 μg/mL, the linear regression equation was: A=2796.7C+163.5 (r=0.9996). The mean recovery was100.1%, RSD = 0.33%. Conclusion:The results show that modafinil and its ordinary impurities can easily be determined by (HPLC).