HPLC法测定塑料药用滴眼剂瓶中7种抗氧剂及其在药品中的迁移

Determination of Seven Antioxidants in Plastic Medicinal Eye Drop Bottles and Their Migration in Medicines by HPLC

建立同时测定塑料药用滴眼剂瓶中7种抗氧剂及其在药品中迁移的高效液相色谱分析方法。样品经超声萃取,采用Shim-pack GIST C18色谱柱进行分离,以甲醇-水为流动相梯度洗脱,流速为1.0 mL/min,柱温为35℃,检测波长为276 nm,进样量为10μL。结果表明:7种抗氧剂在相应的质量浓度范围内线性关系良好(R~2=0.999 9),检出限为0.15~0.31μg/mL,定量下限为0.53~1.04μg/mL,提取实验和迁移实验加标回收率分别为87.02%~105.28%、84.79%~104.77%,各回收率的相对标准偏差(RSD)均不大于4.80%。塑料药用滴眼剂瓶检出6种抗氧剂,含量为3.86~203.54μg/g,滴眼剂中未检出抗氧剂。本方法操作简单、准确可靠,可用于考察塑料药用滴眼剂瓶中抗氧剂及其在药品中迁移。

A high performance liquid chromatographic(HPLC) method was developed for simultaneous determination of seven antioxidants in plastic eye drops bottles and their migration in pharmaceuticals.The samples were ultrasonically extracted and separated by Shim-pack GIST C18 chromatographic column with methanol-water as mobile phase for gradient elution.The flow rate is 1.0 m L/min,the column temperature is 35 ℃,the detection wavelength is 276 nm,and the injection volume is 10 μL.The results show that the seven antioxidants have a good linear relationship in the corresponding mass concentration range(R~2=0.999 9).The detection limit is 0.15~0.31 μg/mL,and the lower limit of quantification is 0.53~1.04 μg/mL.The recoveries of extraction test and migration test are 87.02%~105.28% and 84.79%~104.77%,respectively.The relative standard deviation(RSD) of each recovery is not more than 4.80%.Six antioxidants are detected in plastic medicinal eye drops bottles with the content of 3.86~203.54 μg/g.Antioxidant is not detected in migration test eye drops.The method is simple,accurate and reliable,and can be used to investigate the antioxidants in plastic medicinal eye drops bottles and their migration in medicinal.