论文部分内容阅读
建立了盐酸氯哌丁原料药中的基因毒性杂质2-氯乙醇残留量的测定方法.采用气相色谱-三重四极杆质谱仪, 以多反应监测模式 (MRM) 进行监测.仪器条件为EI源温度:230℃;电子能量:70e V;碰撞气:高纯氮气;碰撞气流速:1.5 m L/min.法线性范围为52.5～840 ng/m L, 线性回归方程为y=0.975065x+13.440439, 相关系数R2=0.9997;平均回收率为99.0％ (n=9), RSD=2.0％;重复性实验RSD=1.3％ (n=6);精密度RSD=0.81％.方法适合用于盐酸氯哌丁原料药中的2-氯乙醇残留量的检测.“,”To establish the method for the determination of genotoxic impurities (2-chloroethanol)in cloperastine hydrochloride. Multiple reaction monitoring mode (MRM)by GC-MS/MS was adopted.The temperature of EI source was 230℃; Electronic energy was 70 e V; Collision gas: nitrogen (1. 5 m L/min). The linear range of calibration curve was 52. 5 ～ 840 ng/m L, equation of linear regression was y = 0. 975065 x + 13. 440439 (R2= 0. 9997); Average recovery was 99. 0％ (RSD =2. 0％, n = 9); RSD of reproducibility was 1. 3％ (n = 6); RSDs of precisionwas 0. 81％ (n = 6). the method has good linear relationship, sensitivity and accuracy, which is suitable for detection of genotoxic impurities (2-chloroethanol)in cloperastine hydrochloride.