HPLC法测定吗替麦考酚酯有关物质的含量Determination of related substances in mycophenolate mofetil by HPLC
张长军,张贵民,于治国
ZHANG Chang-jun,ZHANG Gui-min,YU Zhi-guo
摘要(Abstract)：
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 method for determination of related substances in mycophenolate mofetil.Methods The analysis was performed on an Zorbax SB-C_8 column(250 mm×4.6 mm,5μm)with the mobile phase of acetonitrile-0.3%triethylamine solution(adjusted to pH5.3 by diluted phosphoric acid)(35∶65,V/V).The flow rate was 1.5 mL·min~(-1),and the detection wavelength was set at 250 nm.Results The calibration curves for mycophenolate mofetil and impurity A,B,D,E,F,G,H were linear in each range of concentration(r>0.999).The impurities were well separated in the stress tests.The RSD of precision test,recovery test and stability test were less than 2.0%,respectively.Conclusions The method is specific,sensitive,accurate,robust and suitable for the control of related substances in mycophenolate mofetil.
关键词(KeyWords)：
吗替麦考酚酯;有关物质;高效液相色谱法
mycophenolate mofetil;related substances;HPLC
基金项目(Foundation): 国家科技支撑计划专项-手性药物大品种质量升级专项资助项目(2014BAI16B01)
作者(Author):
张长军,张贵民,于治国
ZHANG Chang-jun,ZHANG Gui-min,YU Zhi-guo
DOI: 10.14066/j.cnki.cn21-1349/r.2017.06.008
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