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编号:11013790
RPHPLC法检查莫达非尼中有关物质及其片剂的含量测定
http://www.100md.com 《广东药学院学报》 2002年第2期
莫达非尼,,莫达非尼;有关物质;高效液相色谱法;含量测定;片剂,1仪器与试药,2方法与结果,3讨论,参考文献
     摘 要 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1 mL/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1.661~4.982μg,即进样量为20μL时的样品ρ=83~249μg/mL范围内,浓度与峰面积线性良好,平均回收率100.11%,RSD=0.33%。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。

    关键词 莫达非尼;有关物质;高效液相色谱法;含量测定;片剂

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

    Abstract 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 249μg/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).

    Key words modafinil;ordinary impurity;HPLC; assay;tablets

    莫达非尼(modafinil)片剂 ......

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