摘要
目的:建立顶空气相色谱法同时测定乙醇、丙酮和乙酸乙酯3种有机溶剂,检查国内已上市注射用美罗培南制剂中残留溶剂,有效评价国内各生产企业的产品与原研药之间的差异,可作为一致性评价的补充依据。方法:使用火焰离子化检测器-气相色谱仪检测,色谱柱为DB-624石英毛细管柱(30 m×0.32 mm,1.80μm),柱温40℃。结果:实验结果显示,3种待测有机溶剂乙醇、丙酮和乙酸乙酯线性关系良好,相关系数均大于0.999,定量限在0.20~0.80μg·mL^(-1),检测限在0.04~0.40μg·mL^(-1),平均回收率在90.79%~100.62%。结论:本法操作简单,结果准确,可测定不同生产企业的注射用美罗培南中残留溶剂,有效判断国内产品与原研药的工艺差别。
Objective:The headspace-gas chromatography method was established for the determination of residual solvents in meropenem for injection as the supplementary for consistency evaluation.Through the investigation of organic solvent residues,the differences between the products of domestic manufacturers and the original drugs were effectively evaluated.Methods:The determination was performed on DB-624 capillary column using the flame ionization detector.The column temperature was 40℃.Results:The calibration curves of three organic solvents showed good linearity(r>0.999).The limit of quantification was 0.20-0.80μg·mL^(-1)and the detection limits was 0.04-0.40μg·mL^(-1).The average recovery was 90.79%-100.62%.Conclusion:The method with simple operation and accurate results cloud determine the residual solvents in meropenem for injection form different manufacturers and effectively judge the process difference between domestic products and RLD.
作者
沈心
周震宇
SHEN Xin;ZHOU Zhen-yu(Suzhou Institute for Drug Control,Jiangsu Suzhou 215104,China)
出处
《中国药物评价》
2023年第4期305-308,共4页
Chinese Journal of Drug Evaluation
关键词
顶空气相色谱法
注射用美罗培南
残留溶剂
一致性评价
Headspace-gas chromatography
Meropenem for injection
Residual solvents
Consistency evaluation
