Development and Validation of Headspace GC-FID Method for Simultaneous Determination of Residual Solvents in Ethyl-3-methyl-3-phenyl Glycidate

摘要

Ethyl-3-methyl-3-phenylglycidate is being used in flavor,fragrance and pharmaceutical industries.Generally acetonitrile,benzene,toluene,methanol and dichloromethane are used as solvent in synthesis of ethyl-3-methyl-3-phenylglycidate.Complete removal of such organic volatile components is not always possible and they may remain at residual level.However,these solvents are harmful and toxic to human as well as in environment above certain concentration.This necessitates the identification of the residual solvents and controlling them within residual solvents acceptance limit set by ICH(Q3C)guidelines.In present work,simple and rapid gas chromatographic method using head space sampler and flame ionization detector have been developed for determination of a residual solvents in ethyl-3-methyl-3-phenylglycidate.This method resulted into a well separation of residual solvents on non-polar capillary columns.The method is validated for precision,recovery,linearity,range and limit of detection as per ICH guideline.