中国药房2013，Vol.24Issue(33)：3152-3154,3.DOI:10.6039/j.issn.1001-0408.2013.33.29
阿莫西林胶囊中高分子聚合物测定方法的改进
Improvement of the Determination Method for High-molecular Polymer in Amoxicillin Capsules
蒋婷 1袁明勇 1郑玲利1
作者信息
- 1. 成都医学院第一附属医院,成都610500
- 折叠
摘要
Abstract
OBJECTIVE:To improve the determination method for the high-molecular polymer in Amoxicillin capsules in Chinese Pharmacopeia (2010 edition).METHODS:RP-HPLC method was adopted.The determination was performed on TSK-GEL G2000SWXL colunm replacing SephadexG-10 gel column with mobile phase consisted of 0.005 mol/L phosphate buffer solution (pH 7.0)-acetonitrile (isocratic elution) replacing phosphate buffer solution (pH 8.0)-water (gradient elution).The sample size was 20 μl instead of 100-200 μl,and the column temperature was 25 ℃.The detection wavelength was set at 254 nm.RESULTS:The peak of high-molecular polymer was completely separated from the main peak of amoxicillin; separation rate was higher than 1.5,and separation time was 20 min around; the number of the theoretical plate was no less than 2 000.The linear range of amoxicillin was 1.528-21.388 μg/ml (r=0.999 9).The RSD of repeatability test was 1.27％ (n=5),and the limit of detection was 6.012 ng.The number of the theoretical plate of primary method was no less than 700,and analysis time was 50 min around.CONCLUSIONS:The new method is of higher column efficiency,more symmetrical peak type,smaller sample size,shorter analysis time,simpler operation and more reliable results,compared to primary method.关键词
阿莫西林胶囊/高分子聚合物/反相高效液相色谱法/分子排阻色谱法/TSK-GEL G2000SWXL色谱柱/含量测定Key words
Amoxicillin capsules/ High-molecular polymer/ RP-HPLC/ Molecular exclusion chromatography/ TSK-GEL G2000SWXL column/ Content determination分类
医药卫生引用本文复制引用
蒋婷,袁明勇,郑玲利..阿莫西林胶囊中高分子聚合物测定方法的改进[J].中国药房,2013,24(33):3152-3154,3.
