Determination of Residues of 5 Organic Solvents in Teicoplanin Raw Material and Injection by Headspace GC
10.6039/j.issn.1001-0408.2015.18.37
- VernacularTitle: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
- Author:
Wenfei GENG
;
Junying WU
;
Chunxia WANG
;
Lemin REN
;
Aibing KE
- Publication Type:Journal Article
- Keywords:
Teicoplanin;
Raw material;
Injection;
Residual solvents;
Headspace GC
- From:
China Pharmacy
2015;(18):2554-2556
- CountryChina
- Language:Chinese
-
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.
