UPLC-MS/MS法测定利奈唑胺中的一种基因毒性杂质  

Determination of genotoxic impurity in linezolid by UPLC-MS/MS

作　　者：李倚天 梅芊[1] 刘英[1] LI Yi-tian;MEI Qian;LIU Ying(Henan Provincial Institute of Food and Drug Control,Zhengzhou 450018)

机构地区：[1]河南省食品药品检验所,郑州450018

出　　处：《中南药学》2022年第5期1172-1175,共4页Central South Pharmacy

摘　　要：目的采用UPLC-MS/MS法快速测定利奈唑胺中基因毒性杂质S-1-氨基-3-氯-2-丙醇盐酸盐的含量。方法使用ACE EXCEL C_(18)-AR(2.1 mm×100 mm,5μm)色谱柱,以0.2%甲酸水溶液-乙腈(70∶30)为流动相,流速为0.3 mL·min^(-1),正离子(ESI^(+))模式下单离子检测扫描模式(SIM)方式检测。结果S-1-氨基-3-氯-2-丙醇盐酸盐在3.013~30.125 ng·mL^(-1)与峰面积线性关系良好(r=0.9997),9批次样品均未检出S-1-氨基-3-氯-2-丙醇盐酸盐。结论该方法简便快捷,准确可靠,适合利奈唑胺中S-1-氨基-3-氯-2-丙醇盐酸盐的快速检测,可为研究其他药物中此类杂质的检测提供参考。Objective To determine S-1-amino-3-chloro-2-propanol hydrochloride in linezolide by UPLC-MS/MS.Methods The analytes were separated on an ACE EXCEL C_(18)-AR(2.1 mm×100 mm,5μm)column with 0.2%formic acid-acetonitrile(70∶30)as the mobile phase.The flow rate was 0.3 mL·min^(-1).The target compound was analyzed by the positive ion single ion monitoring(SIM)mode.Results The linearity of hydrazine was 3.013-30.125 ng·mL^(-1)(r=0.9997).No S-1-amino-3-chloro-2-propanol hydrochloride was detected in the samples.Conclusion This method is simple,accurate and reliable,which is suitable for the rapid detection of S-1-amino-3-chloro-2-propanol hydrochloride in linezolide,which provides a reference for determining S-1-amino-3-chloro-2-propanol hydrochloride impurities in other drugs.

关 键 词：UPLC-MS/MS 遗传毒性杂质 利奈唑胺 S-1-氨基-3-氯-2-丙醇盐酸盐 

分 类 号：R927[医药卫生—药学]