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

VernacularTitle:GC-MS法测定三层共挤输液用袋中苯乙烯单体在氧氟沙星氯化钠注射液中的迁移量
Author: Xinglan LIU ¹ ; Xiaolan WANG ; Ping HUANG
Author Information

1. 四川省食品药品检验检测院成都611731
Keywords: Ofloxacin and sodium chloride injection; Styrenne; Three layer coextrusion infusion bags; GC-MS
From: China Pharmacist 2018;21(1):171-173
CountryChina
Language:Chinese
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 .