| 顶空气相色谱法测定盐酸司他斯汀中6种残留溶剂 |
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| 引用本文： | 夏红英,钟振华,余师师,裴昆,刘贞,程奇珍.顶空气相色谱法测定盐酸司他斯汀中6种残留溶剂[J].分析试验室,2021,40(1):70-74. |
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| 作者姓名： | 夏红英 钟振华 余师师 裴昆 刘贞 程奇珍 |
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| 作者单位： | 江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029;江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029;江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029;江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029;江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029;江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029 |
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| 基金项目： | 江西省药品监督管理局科研项目(2019JS06);国家药品标准提高研究项目(药典综〔2018〕482号,2018H093)资助。 |
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| 摘 要： | 建立了顶空气相色谱法(HS-GC)测定盐酸司他斯汀中乙醚、丙酮、异丙醇、四氢呋喃、甲苯与二甲苯6种有机溶剂残留量的方法.样品用二甲基亚砜溶解,在110 ℃加热20 min,使气液平衡,采用氢火焰离子化检测器(FID),以DB-1701(60 m x 0.320 mm,1.00 μm)为分析柱,程序升温测定.在优化的气相...
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| 关 键 词： | 盐酸司他斯汀 残留溶剂 顶空气相色谱法 |
Determination of six residual organic solvents in setastine hydrochloride by headspace gas chromatography |
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| XIA Hongying,ZHONG Zhenhua,YU Shishi,PEI Kun,LIU Zhen,CHENG Qizhen.Determination of six residual organic solvents in setastine hydrochloride by headspace gas chromatography[J].Chinese Journal of Analysis Laboratory,2021,40(1):70-74. |
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| Authors: | XIA Hongying ZHONG Zhenhua YU Shishi PEI Kun LIU Zhen CHENG Qizhen |
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| Institution: | (Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Dmg and Medical Device Quality,Nanchang 330029) |
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| Abstract: | A headspace gas chromatography(HS-GC)method was established for the determination of six residual solvents including ethyl ether,acetone,isopropanol,tetrahydrofuran,toluene and xylene in setastine hydrochloride.The sample was dissolved in dimethyl sulfoxide,heated at 110℃for 20 minutes in order to reach the vaporliquid equilibrium state,and detected by flame ionization detector(FID).DB-1701 capillary column(60 m×0.320 mm,1.00μm)was used with the column temperature raised by program.Under optimized conditions of HS-GC,the six residual organic solvents were separated well.Good linearities were obtained in the experimental concentration(correlation coefficient:R2=0.9998-1.0000).The average recoveries were in the range from 96.5%to 98.9%(n=9).The method is suitable for the routine detection of the six residual solvents in setastine hydrochloride. |
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| Keywords: | setastine hydrochloride residual organic solvents headspace gas chromatography |
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