摘要
目的:建立检测盐酸莫西沙星氯化钠注射液中苯乙烯单体迁移量的监测方法。方法:采用气相色谱-质谱联用法,色谱柱DB-5MS(30 m×0.25 mm,0.25μm),以大体积顶空吹扫富集测定。结果:苯乙烯在0.009 1~0.364μg·ml^(-1)范围内线性良好(r=0.999 9),苯乙烯在盐酸莫西沙星氯化钠注射液中迁移的平均加样回收率为99.4%(RSD=1.1%,n=9)。经过对多批样品检测,苯乙烯迁移量均在检测限以下。结论:该方法经方法学验证,可用于五层共挤输液袋中残留苯乙烯在盐酸莫西沙星氯化钠注射液中的迁移量的检测。
Objective： To establish a monitoring method for the detection of styrene monomer migration to moxifloxacin hydrochloride and sodium chloride injection. Methods： A GC-MS method with a DB-5MS （30 m × 0.25 mm, 0.25μm） column was used to determine styrene by the manner of large volume headspace purge-trap. Results： The linearity of styrene was good within the range of 0.009 1-0.364 μg·ml - l （ r = 0.999 9） , and the average recovery of styrene in moxifloxacin hydrochloride and sodium chloride injection was 99.4% （RSD = 1.1% , n =9）. After the detection of several batches of samples, the amount of styrene migration was all below the detection limit. Conclusion ： The method can be used to measure the migration of styrene remained in five-layer co-extrusion infusion bags to moxifloxacin hydroehloride and sodium chloride injection.
出处
《中国药师》
CAS
2017年第11期1969-1971,共3页
China Pharmacist
