Objective:To establish a headspace gas chromatography method for determination of ethylene oxide residue in Ni-Ti shape memory alloy elastic polymerizer for medical devices.Methods:Gas chromatography with hydrogen flame ionization detector is performed on HP-INNOWax column.The column temperature is 80℃for 15 min,the inlet temperature is 200℃,the detector temperature is 250℃,the hydrogen flow rate is 35 mL/min,the air flow rate is 350 mL/min,and the balance time is 40 min.Results:The linearity of ethylene oxide is good in 1 μg/mL to 10 μg/mL.The detection limit is 0.01 mg/L,the precision RSD is 0.01%,and the recovery is 86.6%to 96.6%.In order to ensure the accuracy of the results,the sample should be measured immediately and the cutting area should be as small as possible.Conclusion:The method is simple and has low detection limit,and can be used for rapid determination of ethylene oxide residue in Ni-Ti shape memory alloy bone implants.
ethylene oxideheadspace gas chromatographynickel-titanium shape memory alloy bone implants
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