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引用本文:刘秀英,郑世君,王玉梅,陈建征,张桂森.GC测定盐酸氟西汀中二氯甲烷残留量[J].中国现代应用药学,2012,29(9):849-851.
LIU Xiuying,ZHENG Shijun,WANG Yumei,CHEN Jianzheng,ZHANG Guisen.Determination of Residual Dichloromethan in Fluoxetine by GC[J].Chin J Mod Appl Pharm(中国现代应用药学),2012,29(9):849-851.
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GC测定盐酸氟西汀中二氯甲烷残留量
刘秀英, 郑世君, 王玉梅, 陈建征, 张桂森
江苏恩华药业股份有限公司技术中心,江苏 徐州 221007
摘要:
目的 采用气相色谱法检测盐酸氟西汀中的二氯甲烷残留量。方法 色谱柱:DB-624毛细管柱(30 m×0.53 mm);载气:高纯氮气,0.05 MPa;检测器:ECD;进样口温度:150 ℃;检测器温度:300 ℃;柱温为程序升温;进样量:1 μL;分流比:1∶20。结果 二氯甲烷在5.96~71.55 μg·mL-1内,峰面积和浓度之间呈良好的线性关系(r=0.999 6),3批样品中的二氯甲烷残留量均符合规定(<0.06%)。结论 该方法操作简便,精密度好,准确性高,可用于检测盐酸氟西汀中二氯甲烷残留量。
关键词:  气相色谱法  盐酸氟西汀  二氯甲烷
DOI:
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Determination of Residual Dichloromethan in Fluoxetine by GC
LIU Xiuying, ZHENG Shijun, WANG Yumei, CHEN Jianzheng, ZHANG Guisen
Nhwa Pharma Corporation, Xuzhou 221007, China
Abstract:
OBJECTIVE To detect the residue dichloromethane in fluoxetine by gas chromatography(GC). METHODS Residue dichloromethane in fluoxetine was detected by GC with DB-624 column(30 m×0.53 mm), ECD detector and nitrogen as carrier gas(0.05 MPa). Injector and detector temperatures was set at 150 and 300 ℃ respectively. Column temperature was programmed set. Injection volume was 1 μL and the split ratio was 1∶20. RESULTS Dichloromethane showed a good linear relationship in the range of 5.96~71.55 μg·mL-1(r=0.999 6), the residue dichloromethane in three batches of samples coincided with the requirements(<0.06%). CONCLUSION Gas chromatography(GC) is simple, accurate, sensitive. It can be used for the determination of dichloromethane in fluoxetine.
Key words:  GC  fluoxetine  dichloromethane
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