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作 者:黄书浩 韩银[1] 徐萍华[1] 李德升[1] 张莉[1] HUANG Shuhao;HAN Yin;XU Pinghua;LI Desheng;ZHANG Li(Medical Device Supervising and Testing Center of Hangzhou,.State Food and Drug Administration,Hangzhou 310009,China)
机构地区:[1]国家食品药品监督管理局杭州医疗器械质量监督检验中心,杭州310009
出 处:《化学分析计量》2019年第1期38-41,共4页Chemical Analysis And Meterage
基 金:浙江省科技厅项目(2016C37068)
摘 要:建立气相色谱–质谱(GC–MS)联用法与气相色谱(GC)法测定眼用全氟丙烷气体中甲醇、甲醛杂质的方法。甲醇采用GC–MS法定性、GC法定量分析,在51.1~511μL/L浓度范围内线性良好(r^2=0.998 5),检出限为4μL/L,测量结果的相对标准偏差为2.73%(n=6),加标回收率为91%~94%;甲醛采用GC–MS定性、定量分析,质谱选择离子(SIM)模式以m/z 29作为甲醛的定量离子,在21.36~106.8μL/L浓度范围内线性良好(r^2=0.999 1),检出限为5μL/L,测量结果的相对标准偏差为3.19%(n=6),加标回收率为89%~94%。该方法灵敏度高,重复性好,简便可行,可用于眼用全氟丙烷气体的质量控制。A method of gas chromatography-mass spectrometry(GC-MS) and gas chromatography(GC) was established for the determination of methanol and formaldehyde in ophthalmic perfluoropropane gas.Methanol was qualitatively analyzed by GC-MS and quantitatively analyzed by GC,respectively,the linearity was in the concentration range of 51.1-511μL/L with the correlation coefficient (r2) of 0.9985,the detection limit was 4μL/L,the relative standard deviation of the detection data was 2.73%(n=6),and the recovery was 91%-94%.Formaldehyde was qualitatively and quantitatively analyzed by GC-MS with the selected quantitative ion (SIM) of m/z 29,and the linearity was in the concentration range of 21.36-106.8μL/L with the correlation coeffient (r2) of 0.9991,the detection limit was 5μL/L,the relative standard deviation of the detection data was 3.19%(n=6),and the recoveries were 89%-94%.The method has high sensitivity and good repeatability,it is a simple and feasible for quality control of ophthalmic perfluoropropane gas.
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