[Study on gas chromatographic method for the evaluation of residual solvents by using wide bore open tubular columns].
A GC method using wide bore open tubular columns was developed to evaluate residual organic solvents. Sixteen organic solvents commonly used for pharmaceutical synthesis were analysed. The effects of different polarity columns and extraction solvents on the assay of residual solvents were studied in this work. It showed that most solvents can be well separated from each other on non-polar or less polar wide-bore columns. Extraction solvents differed in their extraction recovery and peak shape. Satisfactory results can be obtained when the proposed method was employed and a suitable extraction solvent was selected. The procedures summarized in this paper can be used as a guidance for the evaluation of residual organic solvents in bulk pharmaceuticals.
Yao
Q
Q
School of Pharmacy, West China University of Medical Science, Chengdu 610041, China.
Li
Z W
ZW
Zhang
Q
Q
Ye
L M
LM
D002849:Chromatography, Gas / Q000295:instrumentation* / Q000379:methods; D004340:Drug Contamination; D000431:Ethanol / Q000032:analysis / Q000302:isolation & purification; D000432:Methanol / Q000032:analysis* / Q000302:isolation & purification; D004364:Pharmaceutical Preparations / Q000032:analysis
D004364:Pharmaceutical Preparations; D000431:Ethanol; D000432:Methanol