超高效液相色谱法测定酒石酸溴莫尼定滴眼液瓶中14种抗氧剂的迁移量
Determination of the migration quantity of 14 antioxidants from brimonidine tartrate eye drop bottles by UPLC
黄俊杰 1申兰慧 1王丽 1杨敏智1
作者信息
- 1. 无锡市药品安全检验检测中心,无锡 214000
- 折叠
摘要
目的 建立酒石酸溴莫尼定滴眼液瓶中14种抗氧剂迁移量的检测方法.方法 采用Waters ACQUITY UPLC BEH C18 色谱柱(2.1×100 mm,1.7 μm),以 0.02%甲酸的水溶液-乙腈-四氢呋喃为流动相,梯度洗脱,流速0.4 mL/min,检测波长 210 nm,柱温 35℃,进样量 4 μL.结果 14种抗氧剂之间的分离度均在 1.5以上,各抗氧剂在 0.2-20 μg/mL浓度范围内线性关系良好(r＞0.9990),该方法专属性、精密度、重复性、准确度、稳定性、耐用性均良好.6家企业 6批次样品中共计检出 6种迁移的抗氧剂,分别为抗氧剂 1076、抗氧剂168、抗氧剂 2246、抗氧剂 3114、抗氧剂 445、抗氧剂BHT.结论 该方法检测灵敏度高、分析时间短、方法重复性好、操作简单,可用于测定酒石酸溴莫尼定滴眼液瓶中 14种抗氧剂的迁移量.
Abstract
Objective To establish an UPLC method for monitoring the migration quantity of 14 antioxidants from brimonidine tartrate eye drop bottles.Methods The samples were separated by Waters ACQUITY UPLC BEH C18 chromatographic column with 0.02%formic acid solution-acetonitrile-tetrahydrofuran as mobile phase for gradient elution.The flow rate is 0.4 mL/min,the detection wavelength is 210 nm,the column temperature is 35℃,and the injection volume is 4 μL.Results The resolutions between the 14 antioxidants were greater than 1.5,and the 14 antioxidants have a good linear relationship in the concentration range from 0.2 μg/mL to 20 μg/mL(r＞0.9990).The specificity,precision,repeatability,accuracy,stability and durability of the method were all great.6 kind of antioxidants were detected in the 6 batches of samples from 6 companies,which were antioxidant-1076,168,2246,3114,445 and BHT.Conclusion The method is sensitive,rapid and easy to use with good repeatability,which is available for the determination of the migration quantity of 14 antioxidants from brimonidine tartrate eye drop bottles.
关键词
酒石酸溴莫尼定/滴眼液/超高效液相色谱法/抗氧剂迁移Key words
brimonidine tartrate/eye drops/UPLC/migration of antioxidants引用本文复制引用
出版年
2024
NETL
NSTL
万方数据