聚丙烯安瓿包装的丙酸氟替卡松吸入混悬液中抗氧剂及降解产物提取量和迁移量的测定  

Determination of Extraction and Migration of Antioxidant and Degradation Products in Polypropylene Ampoule Packaging Fluticasone Propionate Inhalation Suspension

作　　者：任静 REN Jing(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203)

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《中国医药工业杂志》2025年第2期244-248,257,共6页Chinese Journal of Pharmaceuticals

摘　　要：建立了HPLC法同时测定聚丙烯安瓿包装中8种抗氧剂及其降解产物的可提取量,及其在丙酸氟替卡松(1)吸入混悬液中的迁移量。采用Poroshell 120 EC-C_(18)色谱柱(4.6 mm×50 mm,2.7 μm),流动相A为0.2%乙酸,B为异丙醇,C为乙腈,梯度洗脱。流速为1.0 mL/min,检测波长为280 nm,柱温为40 ℃。结果显示,8种抗氧剂及其降解产物在0.25~50 μg/mL内线性关系良好,检测限为0.10 μg/mL,定量限为0.25 μg/mL,加标回收率在80.8%~109.9%。在pH 3.5缓冲液、pH 8.0缓冲液、0.9%氯化钠溶液以及50%异丙醇介质中的回收率均在95.2%~107.7%,RSD在0.1%~2.2%。建立的方法操作简便,准确性和重复性良好,为1吸入混悬液的质量控制研究提供参考。An HPLC method was established for simultaneous determination of 8 antioxidants and their degradtionproducts in the extracts from polypropylene ampoule packaging and their migration in the inhalation suspension offluticasone propionate(1).The Poroshell 120 EC-C_(18) column(4.6 mm×50 mm,2.7 μm) was used,and the analysis wascarried out in the gradient elution mode with 0.2% acetic acid as mobile phase A,isopropanol as mobile phase B,and acetonitrileas mobile phase C.The flow rate was 1.0 mL/min,the detection wavelength was 280 nm,and the column temperaturewas 40 ℃.The results showed that it was linear for 8 antioxidants and their degradation products in the range of 0.25-50 μg/mL.The detection limit was 0.10 μg/mL,the quantification limit was 0.25 μg/mL,and the spiked recovery rate werebetween 80.8% and 109.9%.The recovery rates in pH 3.5 buffer,pH 8.0 buffer,0.9% sodium chloride solution,and 50%isopropanol medium were all between 95.2% and 107.7%,with RSDs ranging from 0.1% to 2.2%.The established method is easy to operate,with good accuracy and repeatability,which provide a reference for the quality control research of 1 inhalation suspension.

关 键 词：丙酸氟替卡松吸入混悬液 平喘药 聚丙烯安瓿 抗氧剂 降解产物 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学] R974.3[医药卫生—药学]