Determination of residual organic solvents in pharmaceuticals by headspace gas chromatography

A determination method of residual solvents in pharmaceutical products by headspace gas chromatography has been established and optimized. Eight solvents which belong to the guideline for residual solvents regulated by the International Conference on Harmonization were studied. Under optimum conditions, various components were separated completely. This novel method was applied to the analysis of volatile residual solvents in pharmaceutical products with satisfactory results. The method is simple, accurate and reliable, which can be used to detect the residual solvents in pharmaceutical products.