气相色谱-质谱法测定眼用全氟丙烷气体中甲醇、甲醛
黄书浩,韩银,徐萍华,李德升,张莉
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
Determination of methanol and formaldehyde in ophthalmic perfluoropropane gas by GC-MS
黄书浩,韩银,徐萍华,李德升,张莉
Medical Device Supervising and Testing Center of Hangzhou,. State Food and Drug Administration, Hangzhou 310009, China
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51.1~511 μL/L浓度范围内线性良好(r2=0.998 5),检出限为4 μL/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21.36~106.8 μL/L浓度范围内线性良好(r2=0.999 1),检出限为5 μL/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。
Abstract: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 51.1-511 μL/L with the correlation coefficient (r2) of 0.998 5, the detection limit was 4 μL/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 21.36-106.8 μL/L with the correlation coeffient (r2) of 0.999 1, the detection limit was 5 μL/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.
关键词:全氟丙烷;气相色谱-质谱法;甲醇;甲醛
Keywords:ophthalmic perfluoropropane; GC-MS; methanol; formaldehyde
基金:浙江省科技厅项目(2016C37068)
本文引用格式:
黄书浩,韩银,徐萍华,等.气相色谱-质谱法测定眼用全氟丙烷气体中甲醇、甲醛[J].化学分析计量,2019,28(1):38-41.
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