加替沙星残留溶剂检测方法的改进
Improvement for the Residual solvent in Gatifloxacin Detection Method
张现振 1曹文龙 1李俊广1
作者信息
- 1. 山东罗欣药业股份有限公司 山东省冻干粉针剂药物重点实验室，山东 临沂 276017
- 折叠
摘要
目的：改进加替沙星残留溶剂检测方法。方法色谱柱：聚6％氰丙基苯基-94％二甲基硅氧烷为固定液的色谱柱（30m ×530μm ×3．0μm），载气为氮气，检测器为氢火焰离子化检测器。结果甲醇的质量浓度在24．86-74．58μg/ml范围内与峰面积之间的线性关系良好（r1＝0．9996）；吡啶的质量浓度在5．15-15．44μg/ml范围内与峰面积之间的线性关系良好（r2＝0．9996）；N，N-二甲基甲酰胺的质量浓度在9．77-29．31μg/ml范围内与峰面积之间的线性关系良好（ r3＝0．9995）。结论本方法简便、准确、灵敏度高，适用于加替沙星残留溶剂的检测。
Abstract
Objective Improve the detection method of residual solvent in gatifloxacin .Methods Chromatographic column:Poly 6% cyanide propyl phenyl -94%dimethyl siloxane for fixed liquid chromatographic column(30 m *530 mu m *3.0 microns),carrier gas is nitrogen,detector for hydrogen flame ionization detector. Results The quality of the methanol concentration within 24.86-74.58(including g/ml a good linear relationship with the peak area(r1 =0.9996).Mass concentration of pyridine(including in 5.15-5.15 g/ml within the scope of a good linear relationship with the peak area(r2 =0.9996).The quality of N,N-dimethyl form amide concentration within 9.77-29.31(including g/ml a good linear relationship with the peak area(r3 =0.9995).Conclusion This method is simple,accurat1e,high sen-sitivity,and is applicable for the detection of residual solvents in gatifloxacin .
关键词
加替沙星/残留溶剂/毛细管柱/甲醇/吡啶N,N-二甲基甲酰胺Key words
Gatifloxacin/Residual solvents/Capillary column/Residue/Pyridine N,N-dimethyl formamide引用本文复制引用
出版年
2014
NETL
NSTL
万方数据