Determination of Residues of 5 Organic Solvents in Teicoplanin Raw Material and Injection by Headspace GC / 中国药房

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.