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Simultaneous determination of 9 impurities in doxofylline injection by HPLC

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Author:
No author available
Journal Title:
Central South Pharmacy
Issue:
8
DOI:
10.7539/j.issn.1672-2981.2024.08.038
Key Word:
多索茶碱注射液;高效液相色谱法;杂质;doxophylline injection;HPLC;impurity

Abstract: Objective To determine 9 impurities in doxofylline injection by high performance liquid chromatography(HPLC).Methods A CAPCELL PAK C18 ME column(4.6 mm×250 mm,5 μm)was used.Acetonitrile-phosphate buffered saline was used as the mobile phase,with gradient elution.The flow rate was 1.0 mL·min-1,the column temperature was 30 ℃,and the detection wavelength was 273 nm.Nine possible impurities in doxofylline injection were quantitatized and the limit was checked.Results Under these conditions,the 9 impurities were completely separated,with recoveries between 97.0%~105.0%.Conclusion This method is specific and reproducible,and can be used for the determination of related substances in doxofylline injection.

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