A sensitive estimation of residual ethylene glycol in ethylene oxide sterilized medical devices by HPLC with electrospray ionization mass spectrometric detection

A novel analytical methodology for the estimation of residual ethylene glycol (EG) in ethylene oxide sterilized polymer is reported. The method involves the monitoring of ammonium adduct of EG ions in the presence of 10 mM ammonium acetate buffer and methanol using electrospray ionization liquid chromatography and mass spectrometry (LC–ESI-MS). The method enables the detection and quantification of EG without prior derivatization up to a level of 0.06 μg/ml. The potentiality of the method is demonstrated by estimating EG in ethylene oxide (EtO) sterilized polyethylene terephthalate fabric used in heart valve sewing ring. The method is simple, rapid and can routinely be used for the quantification of residual EG in EtO sterilized medical devices.