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目的建立高效液相色谱法测定吗替麦考酚酯有关物质的含量。方法色谱柱为Zorbax SB-C_8(250mm×4.6mm,5μm)柱,流动相为乙腈-体积分数0.3%三乙胺溶液(用稀磷酸调节pH为5.3)(体积比为35∶65),流速为1.5mL·min~(-1),检测波长为250nm。结果吗替麦考酚酯及其有关物质A、B、D、E、F、G及H在各自的质量浓度内与峰面积线性关系良好(r>0.999);有关物质与主成分色谱峰均具有良好的分离度,强制降解试验中各杂质均获得基线分离,表明本方法专属性良好;精密度、稳定性及回收率试验的相对标准偏差RSD均不大于2.0%。结论本方法具有可用于吗替麦考酚酯的有关物质检查。
Objective To establish a HPLC method for the determination of mycophenolate mofetil related substances. Methods The column was a Zorbax SB-C_8 (250 mm × 4.6 mm, 5 μm) column with a mobile phase of acetonitrile-0.3% triethylamine by volume (adjusted to pH 5.3 with dilute phosphoric acid) (35:65 by volume) 1.5mL · min -1, the detection wavelength was 250nm. Results Mycophenolate mofetil and its related substances A, B, D, E, F, G and H had good linear relationship with peak area (r> 0.999) in their respective mass concentrations; The results showed that the method has good specificity and the relative standard deviations (RSDs) of the precision, stability and recovery tests are not more than 2.0%. Conclusion This method is useful for mycophenolate mofetil related substances.