Determination of Styrene Monomer Migration Amount in Ofloxacin and Sodium Chloride Injection from Three Layer Coextrusion Infusion Bags by GC-MS / 中国药师

ABSTRACT

Objective:To establish a method for determining styrene monomer migration amount in ofloxacin and sodium chloride injection from three layer coextrusion infusion bags by GC-MS.Methods:The styrene monomer content in ofloxacin and sodium chlo-ride injection was detected by GC-MS in order to study the migration amount of styrene from the packaging bag ( three layer coextrusion infusion) of ofloxacin and sodium chloride injection .A DB-624123-1334 capilary column (30 m ×0.32 mm, 1.8 μm) was used, and the detection was carried out with programmed temperature and headspace sampling by the electron bombardment source (EI) in a selective ion monitoring (SIM) mode.Results:The linear concentration range of styrene was 46.96-543.60 ng· ml-1(r=0.9999), and the average recovery was 101.2％(RSD=3.1％, n=9).Conclusion:The method is simple, accurate and reproducible.It can be used for the compatibility testing between medicine and its package .