GC-MS法测定吡拉西坦氯化钠注射液中21种邻苯二甲酸酯类塑化剂  

Determination of 21 phthalic acid ester plasticizers in piracetam sodium chloride injection by GC-MS

作　　者：张迪 岳青阳 李尚颖 隋晓璠 ZHANG Di;YUE Qing-yang;LI Shang-ying;SUI Xiao-fan(Liaoning Center for Inspection,Examination and Certification,Shenyang 110036;Liaoning Institute for Drug Control/NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drug,Shenyang 110036)

机构地区：[1]辽宁省检验检测认证中心,沈阳110036 [2]辽宁省药品检验检测院/国家药品监督管理局化学药品质量研究与评价重点实验室,沈阳110036

出　　处：《中南药学》2022年第9期2147-2150,共4页Central South Pharmacy

基　　金：辽宁省自然科学基金项目(No.2020-MS-074)。

摘　　要：目的 建立吡拉西坦氯化钠注射液中21种邻苯二甲酸酯类塑化剂的检测方法。方法 色谱柱为DB-5MS,载气为氦气,流速为1.0 mL·min^(-1),进样口温度为260℃,柱温为程序升温。电子轰击电离方式,离子源温度为230℃;定量测定采用MRM模式。以31批吡拉西坦注射液为测定对象,测定邻苯二甲酸酯类塑化剂的含量。结果 21种邻苯二甲酸酯类塑化剂分离良好,质量浓度在各自线性范围内与峰面积呈良好的线性关系,检测限为1~20 ng·mL^(-1),加样回收率为90.4%~103.0%。结论 该法分离效果好、准确、灵敏度高,可同时检测吡拉西坦氯化钠注射中21种邻苯二甲酸酯类塑化剂。Objective To establish a method for the determination of phthalic acid ester plasticizers in piracetam sodium chloride injection.Methods The determination was performed on a DB-5MS column at the flow rate of 1.0 mL·min^(-1) with helium as the carrier gas,injector temperature at 260℃ by temperature programming.Electron impact (EI) ionization mode was used,and MRM was used for the quantity analysis.The assays of phthalic acid ester plasticizers in 31 batches of piracetam sodium chloride injection were determined.Results Totally 21 phthalic acid ester plasticizers were completely separated with good linearity under the condition of GC-MS.The average recoveries ranged 90.4%~103.0%,and the detection limit ranged 1~20 ng·mL^(-1).Conclusion The method is efficient,accurate and sensitive,and can be used for the simultaneous determination of 21 phthalic acid ester plasticizers in piracetam sodium chloride injection.

关 键 词：GC-MS 邻苯二甲酸酯类塑化剂 吡拉西坦氯化钠注射液 

分 类 号：R917[医药卫生—药物分析学]