Determination of Residual Solvents in Azithromycin Raw Material by GC
- VernacularTitle:气相色谱法测定阿奇霉素原料中的溶媒残留量
- Author:
Jianlin LEI
- Publication Type:Journal Article
- Keywords:
GC;
Azithromycin;
Residual solvents
- From:
China Pharmacy
2005;0(22):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To determine the contents of the residual solvents including dichloromethane,acetone and ethanol in azithromycin raw material by GC.METHODS:A glass column was used as chromatographic column.The temperature of sample injection was 140℃and column temperature was 160℃.The carrier gas was nitrogen.The column inlet pressure was 30Psi.The detection was performed using hydrogen flame ionization detector.RESULTS:The detection concentrations of dichloromethane,acetone and ethanol were 0.02%～0.1%(r=0.9 995),0.05%～0.25%(r=0.9 994)and 0.02%～0.1%(r=0.9 994),respectively.The average recovery were 99.1%(RSD=1.4%),100.1%(RSD=1.1%)and 99.5%(RSD=1.3%),respectively.All of the three batches of samples were up to the standard with regard to the residual volume of organic solvent residues in azithromycin raw material.CONCLUSION:The method is proved to be accurate,sensitive and reliable,and suitable for the detection of organic solvent residues in azithromycin.
