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引用本文:陆静娴,李文庭,祝明,马临科.GC测定白芍总苷原料药中有机溶剂残留[J].中国现代应用药学,2018,35(11):1709-1712.
LU Jingxian,LI Wenting,ZHU Ming,MA Linke.Determination of Residual Solvents in Total Glucosides of Paeony Raw Material Drug by GC[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(11):1709-1712.
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GC测定白芍总苷原料药中有机溶剂残留
陆静娴, 李文庭, 祝明, 马临科
浙江省食品药品检验研究院, 杭州 310053
摘要:
目的 采用GC同时测定白芍总苷原料药中乙醇、乙酸乙酯和正丁醇3种残留溶剂。方法 检测器为氢火焰离子化检测器(FID),色谱柱为Agilent DB-624石英毛细管柱(30 m×0.53 mm,3.0 μm),溶剂为N,N-二甲基甲酰胺(DMF),程序升温。结果 3种残留溶剂均能完全分离,乙醇、乙酸乙酯和正丁醇分别在24.60~491.98 μg·mL-1r=0.999 8),21.01~420.25 μg·mL-1r=1.000 0),23.37~467.48 μg·mL-1r=0.999 8)内与峰面积呈良好的线性关系,检测限分别为0.002 37%,0.000 08%和0.000 63%。结论 该方法简单可靠,灵敏度高,可用于白芍总苷原料中的残留溶剂控制。
关键词:  白芍总苷  气相色谱法  残留溶剂
DOI:10.13748/j.cnki.issn1007-7693.2018.11.025
分类号:R917
基金项目:
Determination of Residual Solvents in Total Glucosides of Paeony Raw Material Drug by GC
LU Jingxian, LI Wenting, ZHU Ming, MA Linke
Zhejiang Institute for Food and Drug Control, Hangzhou 310053, China
Abstract:
OBJECTIVE To establish a GC method for the content determination of three residual solvents (ethanol, ethyl acetate and N-butanol) in total glucosides of Paeony raw material. METHODS The experiment was carried out by GC with a detector for the hydrogen flame ionization detector (FID) and the column for the Agilent DB-624 capillary column (30 m×0.53 mm, 3.0 μm). The sample was dissolved in DMF solvent. Program temperature was used in the whole process. RESULTS Three residual solvents were separated completely, the linear ranges of ethanol, ethyl acetate and N-butanol were 24.60-491.98 μg·mL-1 (r=0.999 8), 21.01-420.25 μg·mL-1 (r=1.000 0) and 23.37-467.48 μg·mL-1 (r=0.999 8), respectively. The limit of detection was 0.002 37%, 0.000 08% and 0.000 63%. CONCLUSION The method is simple, sensitive and accurate for the quality control of residual solvents in total glucosides of Paeony raw material.
Key words:  total glucosides of Paeony  gas chromatography (GC)  residual solvent
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