中国药房Issue(18)：2554-2556,3.DOI:10.6039/j.issn.1001-0408.2015.18.37
顶空气相色谱法测定替考拉宁原料药及注射剂中5种有机溶剂残留量
Determination of Residues of 5 Organic Solvents in Teicoplanin Raw Material and Injection by Headspace GC
耿文飞 1吴军营 1王春霞 2任乐民 1可爱兵1
作者信息
- 1. 华北制药集团新药研究开发有限责任公司/微生物药物国家工程研究中心/河北省工业微生物代谢工程技术研究中心，石家庄 050015
- 2. 河北省食品药品检验院，石家庄050011
- 折叠
摘要
Abstract
OBJECTIVE:To establish the method for the residues determination of 5 organic solvents in teicoplanin raw materi-al and injection. METHODS:Headspace GC was performed on the column with 6% cyanopropylphenyl-94% dimethyl polysiloxane (DB-624)as the stationary phase capillary column,the carrier gas was nitrogen,using the temperature program. The temperature of inlet was 200 ℃,detector was hydrogen flame ionization detector with the flow rate of 1 ml/min,split ratio was 40 ∶ 1 and the vol-ume was 1 ml. RESULTS:Good linearity of ethanol,acetone,ethyl acetate,tetrahydrofuran and triethylamine were obtained(r were 0.999 0-0.999 3);the average recoveries were respectively 95.6%,97.0%,103.2%,94.3%and 98.2%(RSD were 2.1%-4.9%, n=9);RSDs of precision and repeatability tests ≤2.6%;and the minimum detectable concentration were respectively 2,2,2,0.7 and 0.3 μg/ml. CONCLUSIONS:The established method is rapid,sensitive and accurate,and can be used for the residues determi-nation of organic solvents in teicoplanin raw materials and injection.关键词
替考拉宁/原料药/注射剂/残留溶剂/顶空气相色谱法Key words
Teicoplanin/Raw material/Injection/Residual solvents/Headspace GC分类
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耿文飞,吴军营,王春霞,任乐民,可爱兵..顶空气相色谱法测定替考拉宁原料药及注射剂中5种有机溶剂残留量[J].中国药房,2015,(18):2554-2556,3.
