Determination of process impurities and degradation products in Doxofylline Injection by HPLC
LIU Xugui
HAO Yanqi
DING Shanshan
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.
Keywords：DoxofyllineTheophyllineHPLCImpurity
Publication Date：2016-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 646-649 )