医药导报2011，Vol.30Issue(4)：503-505,3.DOI:10.3870/yydb.2011.04.035
高效凝胶色谱法测定注射用盐酸头孢甲肟中的高分子杂质
Determination of High Molecular Polymers in Cefmenoxime Hydrochloride for lnjection by High Performance Gel Filtration Chromatography
晏菊姣 1张建波 2付丽娟1
作者信息
- 1. 武汉市食品药品检验所,430012
- 2. 咸宁学院药学院,湖北咸宁,437000
- 折叠
摘要
Abstract
Objective To establish a method for determination of high molecular polymers in cefmenoxime hydrochloride for injection. Methods The chromatographic column was Tsk-gel G2000 SWxl( 300 minx7.8 mm,5 μm )and mobile phase was 0.005 mol · L-1 phosphate buffer( pH7.0 ): acetonitrile( 95 : 5 ). The flow rate was at 0.8 mL · min -1, the detection wavelength was 234 nm and the loading volume was 20 μL. Results The good linear relationships were showed between the sum of peak area of high polymer impurity and concentration of solution for the tested at the range of 0. 067-2. 700 mg · mL-1 ( r=0. 998 8 ) and for cefinenoxime hydrochloride at the range of 0. 001-0. 010 mg · mL 1( r= 0. 999 9 ),respectively. Conclusion The method is simple, reproducible and reliable, which can be used for quality control of high molecular polymers in cefinenoxime hydrochloride for injection.关键词
头孢甲肟,盐酸/高分子杂质/色谱法,高效凝胶分类
医药卫生引用本文复制引用
晏菊姣,张建波,付丽娟..高效凝胶色谱法测定注射用盐酸头孢甲肟中的高分子杂质[J].医药导报,2011,30(4):503-505,3.
