药学研究2016，Vol.35Issue(11)：646-649,4.DOI:10.13506/j.cnki.jpr.2016.11.007
HPLC法测定多索茶碱注射液中的工艺杂质及降解产物
Determination of process impurities and degradation products in Doxofylline Injection by HPLC
刘绪贵 1郝彦齐 2丁珊珊3
作者信息
- 1. 山东大学药学院，山东 济南 250012
- 2. 山东齐都药业有限公司，山东省脑神经保护类药物重点实验室，山东 淄博 255400
- 3. 山东齐都药业有限公司，山东省脑神经保护类药物重点实验室，山东 淄博 255400
- 折叠
摘要
Abstract
Objective To establish an HPLC method for the determination of process impurities and degradation prod-ucts in Doxofylline Injection.Methods The assay was performed on an Agilent TC-C18 column(4.6 mm×250 mm,5 μm) with acetonitrile-phosphate buffer(pH 5.0)(20: 80)as mobile phase,the flow rate was 1.0 mL·min-1 ,the column tem-perature was 30 ℃ and the detection wavelength was 274 nm.Results Good linearity was obtained in 0.031~9.62,0.043~9.080 and 0.126~ 10.561 μg·mL-1 for theophylline,impurity B and inmpurity D,respectively.The correlation coefficient was at least 0.999.The average recovery rates of theophylline,impurity B and impurity D were 101.4%( RSD = 0.3%), 99.3%(RSD= 0.9%),96.6%(RSD= 1.4%),n= 9.Conclusion The method can be used for the determination of process impurities and degradation products in Doxofylline Injection with high sensitivity,accurate and reliable results.关键词
多索茶碱/茶碱/高效液相色谱/杂质Key words
Doxofylline/Theophylline/HPLC/Impurity分类
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刘绪贵,郝彦齐,丁珊珊..HPLC法测定多索茶碱注射液中的工艺杂质及降解产物[J].药学研究,2016,35(11):646-649,4.
