顶空气相色谱法测定碳青霉烯类抗生素药物中的7种残留溶剂  

Determination of Seven Residual Solvents in Carbapenem Antibiotic Drugs by Headspace-GC

作　　者：王茉莉 李聪颖 王梦娜 李香荷 WANG Moli;LI Congying;WANG Mengna;LI Xianghe(Hebei Institute of Drug and Medical Device Inspection and Research,Shijiazhuang 050020,China)

机构地区：[1]河北省药品医疗器械检验研究院,河北石家庄050020

出　　处：《生物化工》2024年第6期50-54,共5页Biological Chemical Engineering

基　　金：2022年度河北省药品监督管理局科技计划项目(2022ZC1031)。

摘　　要：目的:建立顶空气相色谱法测定碳青霉烯类抗生素中的7种残留溶剂(甲醇、乙醇、丙酮、正丙醇、乙酸乙酯、四氢呋喃及二氯甲烷)。方法:采用6%氰苯基丙基+94%二甲基聚硅氧烷为固定相的毛细管柱(60 m×0.53 mm,3μm),进样口温度为200℃,检测器温度为250℃,分流比为2∶1。结果:7种残留溶剂在各自范围内线性关系良好(r> 0.999 0),检测限为0.02~1.80μg/mL,定量限为0.06~3.61μg/mL,7种溶剂低、中、高浓度水平的平均回收率在94.28%~107.79%。结论:该方法操作简便、专属性强、灵敏度高,可同时测定碳青霉烯类抗生素药物中7种溶剂的残留量。Objective:To establish a headspace gas chromatography method for the determination of seven residual solvents in carbapenem antibiotics,including methanol,ethanol,acetone,n-propanol,ethyl acetate,tetrahydrofuran and dichloromethane.Methods:A capillary column(60 m×0.53 mm,3μm)is used as stationary phase with 6%cyanophenylpropyl plus 94%dimethylpolysiloxane as stationary phase,the injection port temperature is 200℃,the detector temperature is 250℃,the split ratio is 2 to 1.Results:The linear relationship between the seven residual solvents is good(r greater than 0.9990),the detection limit is 0.02μg/mL to 1.80μg/mL,the limit of quantification is 0.06μg/mL to 3.61μg/mL.The recovery rate of seven residual solvents at low,medium and high concentrations are 94.28%to 107.79%.Conclusion:The method has strong specificity,high sensitivity,simple and rapid experimental operation,and can be used for the simultaneous determination of seven residual solvents in carbapenem antibiotic drugs.

关 键 词：顶空气相色谱法 碳青霉烯类抗生素 残留溶剂 

分 类 号：O657.7[理学—分析化学]