Determination of impurities in pharmaceutical products using two-stage capillary gas chromatography

摘要

The method of determining impurities in pharmaceutical products using two-stage capillary gas off-line chromatography is presented. The method is based on repeated impurity concentration in a cartridge with a sorbent in the outlet of a capillary column with the following thermodesorption and the concentrate analysis. Concentration and thermodesorption conditiona are optimized using the example of model compounds benzodiazipines. The degree of trapping from the gaseous phase flux in optimal conditions is over 75 percent and the thermodesorption degree is about 90 percent for all model compositions. On the base of the model mixture the possibility of impurity concentration content determination in pharmaceutical products at 10~(-3) percent level is shown.