气相色谱法测定左氧氟沙星中的N-甲基哌嗪  

Determination of N-methyl Piperazine in Levofloxacin Tablets by GC

作　　者：牛明玉 张雅琴 朱琼 胡丽娜 NIU Ming-yu;ZHANG Ya-qin;ZHU Qiong;HU Li-na(Yangtze River Pharmaceutical Group of Jiangsu HAI-CI Biological Pharmaceutical Co.,Ltd.,Jiangsu Taizhou 225300,China)

机构地区：[1]扬子江药业集团江苏海慈生物药业有限公司,江苏泰州225300

出　　处：《广州化工》2018年第2期107-108,153,共3页GuangZhou Chemical Industry

摘　　要：建立左氧氟沙星中残留溶剂N-甲基哌嗪测定的GC分析方法。样品用哌啶溶解,色谱系统以CP-Si L8CB CP759630 m×0.32 mm×1.0μm为色谱柱,采用程序升温模式。取N-甲基哌嗪作为外标物,按外标法以峰面积计算。研究发现,N-甲基哌嗪在一定浓度范围时,线性关系良好;检测限(S/N=10)为10.04μg/m L;系统适用性RSD(n=6)为2.58%。结果表明,该方法简单、准确,重复性好且专属性强,可用于左氧氟沙星中N-甲基哌嗪含量的检测。A GC method for determination of N-methyl piperazine in Levofloxacin Tablets was established.Samples were solved with piperidine.The content of N-methyl piperazine was detected after the separation in a CP-SiL8CB CP7596 column(30 m×0.32 mm,film 1.0μm).A quantitative analytical method was established for N-methyl piperazine by calculated the peak aeras.The calibration curve was linear over the range,the limit of quantification(S/N=10)was 10.04μg/mL,RSD of the system suitability was 2.58%(n=6).According to the results,the method was simple,accurate,reproducible and specific,which can be used for the determination of N-methyl piperazine.

关 键 词：左氧氟沙星 N-甲基哌嗪 残留溶剂 外标法 气相色谱法 

分 类 号：R917[医药卫生—药物分析学]