Analysis of residual Ethylene Oxide in Intraocular lenses using HS-GCMS

Linearity of five different concentration levels of EtO, ranging from 100ppb to 5000ppb was plotted and regression coefficient was found to be >0.99. EtO Standard of 1.0ppm concentration was subjected to reproducibility study and % RSD observed for six injections was < 5.0%. LOD and LOQ levels of 5ppb and 15ppb were achieved respectively, with above standards.

The intraocular lenses, procured from market, were analyzed for presence of residual EtO. All the lenses were found to be having residual EtO less than Method Detection Limit (MDL). For confirmation, recovery studies were carried out by spiking 100ppb EtO standard solution. Recovery obtained for spiked standard solution was within 80% to 120%.

Ultra Fast Scanning Speed and Advanced Scanning Speed Protocol (ASSP)TM were found to be key features of Shimadzu GCMS system to achieve lower detection and quantification levels. With the help of new Head Space HS-20, good reproducibility and linearity could be achieved with no carryover effect.