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Determination of process impurities and degradation products in Doxofylline Injection by HPLC
Author(s): 
Pages: 646-649
Year: Issue:  11
Journal: Qilu Pharmaceutical Affairs

Keyword:  DoxofyllineTheophyllineHPLCImpurity;
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.
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