医药导报Issue(6)：775-778,4.DOI:10.3870/yydb.2014.06.025
聚乙交酯丙交酯中有机溶剂残留的测定
Determination of Residual Organic Solvents in Poly(lactic-co-glycolide)
摘要
Abstract
Objective To establish a capillary gas chromatography( GC)method for the determination of residual organic solvents in poly( lactic-co-glycolide)( PLGA),including methanol,acetone,dichloromethane,and toluene. Methods A capillary GC method was carried out. DB-624 capillary column(30 m× 0. 32 mm,1. 80 μm)with programmed temperature chromatography was employed. The initial temperature was kept at 40 ℃ for 8 min. Then the temperature was raised to 200 ℃ at a rate of 10 ℃·min-1 . The injection port temperature was 180 ℃,and the split ratio was 10:1. The carrier gas was nitrogen. The temperature of FID was set at 250 ℃,and the sample volume was set at 3 μL. Results Four residual organic solvents consisting of methanol,acetone,dichloromethane and toluene in PLGA were completely separated. The linear range of concentration of methanol,acetone,dichloromethane and toluene was within 10. 0-50. 0( r=0. 999 8 ),16. 7-83. 3( r=0.9998),2.0-10.0(r=0.9993),and3.0-14.8(r=0.9997)μg·mL-1,respectively.Therecoveryofmethanol,acetone, dichloromethane and toluene was 99. 9%( RSD=1. 5%),100. 8%( RSD=0. 9%),100. 1%( RSD=1. 1%),and 99. 5%(RSD=0. 6%),respectively. Six batches of samples met the requirements. Conclusion The method is proven to be sensitive and accurate after the validation. It is suitable for the determination of residual organic solvents in PLGA.关键词
聚乙交酯丙交酯/色谱法,气相/残留溶剂Key words
Poly( lactide-co-glycolide)/Chromatography,gas/Residual solvents分类
医药卫生引用本文复制引用
帅放文,章家伟,王向峰,张婷,王宇彤,周宏灏..聚乙交酯丙交酯中有机溶剂残留的测定[J].医药导报,2014,(6):775-778,4.基金项目
科技部重大新药创制项目 （）
