Determination of Residual Cyclohexanone in Disposable Infusion Set by Gas Chromatography
10.3969/j.issn.1671-7104.2014.05.019
- VernacularTitle:气相色谱法测定一次性使用输液（血）器中环己酮的残留量
- Author:
Li ZHANG
1
;
Yan WEN
;
Tao HE
;
Minzhu WANG
;
Pinghua XU
Author Information
1. 国家食品药品监督管理局杭州医疗器械质量监督检验中心
- Keywords:
disposable infusion set;
capilaty gas chromatography;
cyclohexanone;
adhesive
- From:
Chinese Journal of Medical Instrumentation
2014;(5):381-382,385
- CountryChina
- Language:Chinese
-
Abstract:
An effective GC method was established for contents determination of the residual solvent of cyclohexanone in infusion sets for single use, The cyclohexanone in infusion sets for single use products were extracted with circular pump, using ethylalcohol as the extraction solven, then the extract folowed by analysis of gas chromatography-tandem mass spectrometry, The method was simple, rapid, sensitive and accurate, Cyclohexanone showed good linearity in the range of (5.5~190.9)mg/mL, the correlation coefficient was 0.999 0, the detection limit (S/N=3) was 0.133mg/mL and limits of quantitation(S/N=10) was 1.33mg/mL, The spiked average recoveries ranged from 98% to 99%. The relative standard deviations( RSDs) of the method ranged from 1.03% to 1.98%. The method was simple, fast, sensitive and accurate,and may serve as a mass control method for residual cyclohexanone in disposable infusion sets for single use.
