Journal of Hebei Medical University

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Determination of related substances in lansoprazole for injection by high performance liquid chromatography

  

  1. 1. DepartmentofPharmacy , theSecondHospitalofHebeiMedicalUniversity , Shijiazhuang
    050000 , China ; 2. CollegeofBasicMedical , NorthChinaUniversityofScienceandTechnology ,
    Hebei , Tangshan 063000 , China ; 3. DepartmentofPharmacy , HebeiMedical
    University , Shijiazhuang 050017 , China
  • Online:2016-01-25 Published:2016-04-27

Abstract:  Objective Tousehighperformanceliquidchromatographyforthedetermination
ofthecontentoflansoprazoleandlansoprazoleinjection.Methods Thedetermination was
carriedoutonwithaDikmaDiamonsilTM2C 18 ( 4. 6mm×250mm , 5 μ m ) column.Themobile
phasewasmethanol-water ( 70∶30 ) .Thedeterminationwavelengthwas285nm.Results The
excipientsdidnotinterferewiththedeterminationoflansoprazole.Thedevelopedmethodcould
beusedforthe determination oflansoprazoleanditsinjection.The calibration curve of
lansoprazolewasingoodlinearityovertherangeof50-500mg
/ L.Theprecisionofthemethod
(
relativestandarddeviation [ RSD ] =0.14% ) wasgood.Theaveragerecoveryofthelow ,
medium , andhighconcentrationswere100.0% , 98.3% , 101.7% with RSD0.5% , 0.3% ,
0.4%respectively.Conclusion Themethodissimple , accurateandspecific.Itcanbeusedfor
thedeterminationoflansoprazole.

Key words: lansoprazole , chromatography, highperformanceliquid , contentdetermination