中国药房2016，Vol.27Issue(33)：4730-4732,3.DOI:10.6039/j.issn.1001-0408.2016.33.41
HPLC法测定妥舒沙星环合物中的有关物质
Determination of Related Substances in Tosufloxacin Cyclizaton by HPLC
章激1
作者信息
- 1. 湖北文理学院附属医院，湖北襄阳 441021
- 折叠
摘要
Abstract
OBJECTIVE:To establish a method for the determination of related substances in tosufloxacin cyclizaton. METH-ODS:HPLC was performed on the column of YMC-Pack ODS A-312 with mobile phase of acetonitrile-water(5∶3,V/V)at a flow rate 1.2 ml/min,detection wavelength was 250 nm,column temperature was 25℃ and injection volume was 10 µl. RESULTS:The main component and related substances could be baseline separated by the conditions;the linear range was 0.04-1.8 μg/ml(r=0.999 9);the limit of quantification was 40.56 ng/ml and the limit of detection was 6.3 ng/ml;RSDs of precision,stability and re-producibility tests were lower than 3%;recovery was 99.88%-100.68%(RSD=0.29%,n=9);the result of total impurities of 6 batches of sample were less than 0.1%. CONCLUSIONS:The method is specific,sensitivity with high accuracy and precision, and can be used for the determination of related substances in tosufloxacin cyclizaton.关键词
妥舒沙星环合物/高效液相色谱法/有关物质Key words
Tosufloxacin cyclizaton/HPLC/Related substance分类
医药卫生引用本文复制引用
章激..HPLC法测定妥舒沙星环合物中的有关物质[J].中国药房,2016,27(33):4730-4732,3.
