Development and validation of a headspace gas chromatographic method for determination of residual solvents in five drug substances
نویسنده
چکیده
A simple and sensitive method for the simultaneous determination of ethanol, ethyl acetate, tetrahydrofuran, 2-propanol, hexane, dichloromethane and methanol in five drug substances by headspace techniques with FID detection is described. The method was validated for repeatability, linearity, limit of detection, limit of quantification and recovery according to the International Conference on Harmonization guidelines. Excellent results were obtained, within the globally accepted validation reference values, particularly taking into account the low concentration levels investigated
منابع مشابه
Multiple responses optimization in the development of a headspace gas chromatography method for the determination of residual solvents in pharmaceuticals☆
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