中国药物评价2024，Vol.41Issue(2)：120-123,4.
桂利嗪原料中有害残留溶剂三氯甲烷和苯的检测
Determination of Harmful Residual Solvent Trichloromethane and Benzene in Cinnarizine Material
王鹏 1刘贞 1郭艳芳 1钟振华1
作者信息
- 1. 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,江西南昌 330029
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摘要
Abstract
Objective:To establish GC method for determination of residual organic solvent Trichloromethane and Benzene in cinnariz-ine API.Methods:GC was used with DB-624(60 m × 0.32 mm × 1.80 μm)Capillary column.The detector was FID,Inlet temperature was 250 ℃.Temperature programming:the initial column temperature was 55 ℃,kept for 10 min,and then rised to 220 ℃ with a rate of 20 ℃·min-1 and kept for 5 min.The detector temperature was 280 ℃.The flow rate was 3.0 mL·min-1;split ratio was 5∶1.Headspace sampling was used with an temperature of equilibrium at 90 ℃ and an equilibrium time 20 min.Results:The linear equations of trichloromethane(1.50-18.04 μg·mL-1)and benzene(0.050-0.603μg·mL-1)were in good linear range(r＞0.999).The average recovery of trichloromethane and benzene were 97.5％(RSD=2.0％)and 97.7％(RSD=3.1％).Conclusion:The method is sensitive and accurate with good reproducibility,which can be used to determine the contents of trichloromethane and benzene in cinnariz-ine API.关键词
桂利嗪原料药/残留溶剂/三氯甲烷/苯/气相色谱Key words
Cinnarizine API/Residual solvent/Trichloromethane/Benzene/Gas chromatography分类
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王鹏,刘贞,郭艳芳,钟振华..桂利嗪原料中有害残留溶剂三氯甲烷和苯的检测[J].中国药物评价,2024,41(2):120-123,4.
