Determination of related substances in Roflumilast Tablets by HPLC method
LIU Ting
ZHANG Luyong
LIU Shibu
ZHANG Dousheng
Abstract：Objective To establish a method for the determination of related substances in Roflumilast Tablets by HPLC method.Methods A Zorbax SB-C18 (4.6 mm×150 mm,5 μm)column was adopted,the mobile phase was consisted of 0.005 mol·L-1potassium dihydrogen phosphate-acetonitrile with gradient elution at a flow rate of 1.0 mL·min-1,and the detection wavelength was 250 nm.Results In the appropriate concentration range,roflumilast and the impurities peak area showed a good linear relationship with the concentration,the correlation coefficients were greater than 0.999.Conclusion The method was rapid,sensitive,accurate,and suitable for the determination of related substances in Roflumilast Tablets.
Keywords：RoflumilastTabletsRelated substancesHPLC
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 322-326 )