药用丁基胶塞中抗氧剂——BHT和硫化剂——可提取硫的测定
发布时间：2018-04-05 05:20
本文选题：药品包装容器 切入点：丁基胶塞 出处：《药物分析杂志》2017年04期
【摘要】：目的:建立药用丁基橡胶塞中添加剂[抗氧剂264(2,6-二叔丁基-4-甲基苯酚,简称BHT)和硫化剂可提取硫]的含量测定方法。方法:以二氯甲烷-无水乙醇为提取溶剂,利用高效液相色谱法对药用丁基橡胶塞的BHT和可提取硫含量进行测定,以含0.1%三氟乙酸的乙腈-含0.1%三氟乙酸的水(90∶10)为流动相,流速1.0 m L·min~(-1),检测波长280 nm。结果:抗氧剂BHT的线性检测范围0.41~103.00μg·mL~(-1)(r~2=1.000),可提取硫的线性检测范围0.10~103.50μg·mL~(-1)(r~2=0.999 9),BHT和可提取硫的平均回收率分别为95.2%和86.8%。测定7批药用胶塞中BHT与可提取硫含量范围分别为4~206μg·g~(-1)和1~143μg·g~(-1)。结论:本文建立的检测方法经方法学验证,可用于考察药用丁基橡胶塞中BHT和可提取硫的含量及质量控制。
[Abstract]:Objective: to establish a method for the determination of sulfur in butadiene rubber stoppers [antioxidant 264x2O2-di-tert-#china_person0# -4-methylphenol (BHT-4-methyl phenol) and sulphide].Methods: using dichloromethane and anhydrous ethanol as extraction solvent, BHT and extractable sulfur content of butyl rubber plug were determined by HPLC. Acetonitrile containing 0.1% trifluoroacetic acid and water containing 0.1% trifluoroacetic acid were used as mobile phase.The flow rate was 1.0 mL / min and the detection wavelength was 280 nm.缁撴灉:鎶楁哀鍓侭HT鐨勭嚎鎬ф娴嬭寖鍥，
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