摘要
目的采用液相色谱-质谱法(LC-MS)联用对磷酸芦可替尼强制降解后的产物进行色谱分离,并对其结构进行鉴定。方法对各降解杂质进行分离的液相色谱法以YMC Triart C_(18)(4.6 mm×150 mm,3μm)为色谱柱;以甲醇和水为流动相,梯度洗脱;检测波长230 nm。同时采用LC-MS法,运用UPLC串联6540B Q-TOF仪器对主要的降解产物进行初步定性研究。结果对磷酸芦可替尼各降解产物进行了有效分离,并初步鉴定出11个主要降解产物的结构。结论本法可用于磷酸芦可替尼有关物质的检测,为其药品质量的控制提供了参考。
Objective To separate and identify the forced degradation products of ruxolitnib phosphate by liquid chromatography-mass spectrometry(LC-MS).Methods The separation was performed on a YMC Triart C_(18) column(4.6 mm×150 mm,3μm)by gradient elution with methanol water buffer.The UV detection wavelength was 230 nm.The main degradation products were qualitatively studied by UPLC in series with 6540b Q-TOF.Results The degradation products of ruxolitnib phosphate were effectively separated and 11 degradation products were preliminarily identified.Conclusion The method can be used for the determination of related substances in ruxolitnib phosphate,which can provide basis for the drugs quality control.
作者
刘发贵
孙丽霞
李敏
刘思光
李铁健
张贵民
LIU Fa-gui;SUN Li-xia;LI Min;LIU Si-guang;LI Tie-jian;ZHANG Gui-min(Shandong New Times Pharmaceutical Co.Ltd.,Linyi Shandong 273400;Lunan Pharmaceutical Group Co.Ltd.,Linyi Shandong 276002)
出处
《中南药学》
CAS
2022年第4期893-897,共5页
Central South Pharmacy
