HPLC法测定药用胶塞中常用抗氧剂及可提取硫向丙泊酚中/长链脂肪乳注射液中的迁移
Determination of migration of common antioxidants and extractable sulfur in medical rubber stoppers to propofol medium/long chain fat emulsion injection by HPLC
成婕 1江燕 1邱怡婷 1任锟 1赵津池 2田甜 1张罗红1
作者信息
- 1. 四川省药品检验研究院,成都 610097
- 2. 成都康华生物制品股份有限公司,成都 610199
- 折叠
摘要
目的:建立一种高效液相色谱方法(HPLC),用于考察药用胶塞中常用抗氧剂及可提取硫的提取情况,以及药用胶塞中抗氧剂及可提取硫向丙泊酚中/长链脂肪乳注射液的迁移情况.方法:采用Waters Symmetry RP18(250 mm ×4.6 mm,5 μm)色谱柱,流动相为甲醇-乙腈-1％醋酸水溶液,梯度洗脱,检测波长为277 nm,流速为1 mL·min-1,柱温为35℃.结果:各组分分离度良好;在0.1～20 μg·mL-1范围内线性关系良好,r≥0.999 6;该方法的精密度、稳定性、重复性均良好,RSD均＜5.0％;回收率为93.3％～108.7％,RSD为1.8％～12.5％.检出3批药液中均有抗氧剂BHT的迁移,且含量高于其相应人每日允许最大暴露量(PDE)值,有较大安全性风险.结论:该方法具有较高的灵敏度,操作简便,能够用于检测丙泊酚中/长链脂肪乳注射液中抗氧剂的迁移.
Abstract
Objective:To establish a high-performance liquid chromatography(HPLC)method for investigating the extraction of common antioxidants and extractable sulfur in medical rubber stoppers and the migration of antiox-idants and extractable sulfur to propofol medium/long chain fat emulsion injection.Methods:Waters Symmetry RP18(250 mm ×4.6 mm,5 μm)was used as chromatographic column with methanol-acetonitrile-1％acetic acid solution as the mobile phase.Detection wavelength,velocity of flow and column temperature were set to 277 nm,1 mL·min-1 and 35 ℃.Results:Good resolution and linear relationship(r≥0.999 6)in the range of 0.1-20 μg·mL-1 were achieved.This method possesses superior precision,stability,repeatability,and all RSD were less than 5％.The rate of recovery was 93.3％-108.7％,and the RSD was 1.8％-12.5％.The migration of antioxidant BHT was detected in three batches of solution and the content was higher than its corre-sponding permitted daily exposure(PDE)value,which means there is a large safetyrisk.Conclusion:The meth-od represents high sensitivity and is easy to operate,which can effectively detect the migration of antioxidants in propofol medium/long chain fat emulsion injection.
关键词
高效液相色谱法/丙泊酚中/长链脂肪乳注射液/抗氧剂/可提取硫Key words
high-performance liquid chromatography(HPLC)/propofol medium and long chain fat emulsion in-jection/antioxidants/extractable sulfur引用本文复制引用
出版年
2024
NETL
NSTL
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