Residual solvents determination in the antibiotic L-749,345 by static headspace gas chromatography

An automated static headspace gas chromatographic method for the determination of residual solvents in the antibiotic L-749,345 was developed and validated. Headspace analysis was used when direct injection of the compound was found to significantly degrade the performance of the column stationary phase. Quantitation was performed by external standard analyses and the method was found to be precise, linear, sensitive, accurate and rugged. The chromatographic conditions and headspace parameters were optimized in a separate experiment to provide a limit test for trace levels of methylene chloride in the presence of significant levels of ethanol. (C) 1998 Elsevier Science B.V.