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Journal of Kunming Metallurgy College ›› 2024, Vol. 40 ›› Issue (6): 34-.DOI: doi:10.3969/j.issn.1009-0479.2024.06.006

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ValidationofMethodologyforDeterminationofMethylBenzenesulfonate#br# ImpuritiesinValsartanAmlodipineTabletsbyHPLC#br#

  

  1. (FacultyofResourcesandEnvironmentalEngineering,YunnanVocationalInstituteof
    EnergyTechnology,Qujing655001,Yunnan,China)
  • Online:2024-07-04 Published:2025-07-07

Abstract: Abstract:Themethodfordeterminationofmethylbenzenesulfonateinvalsartanamlodipinetabletswas
validated.GradientelutionwasperformedonAgelaVenusilXBPC18(L)column(46×150mm,
5μm,150A)with1% triethylaminephosphatebuffer(pH=28)-acetonitrileasmobilephase.The
detectionwavelengthwas216nm,thecolumntemperaturewas40℃,theflowratewas10mL/min,
thesamplevolumewas50μL,thesolventwasacetonitrilewater(50∶50),andthecontentofmethyl
benzenesulfonateinValsartanamlodipinetabletswasdetermined.Thedetectedamountofmethylbenze
nesulfonateshallnotexceed43ppmaccordingtothepeakareacalculationbyexternalstandardmethod.
Itwasfoundthatmethylbenzosulfonatehadagoodlinearrelationshipintheconcentrationrangeof0049
~055μg/mL(limit10~77mg/L)(r=09998).Thelimitofquantificationwas0049μg/mL,
theRSDofretentiontimewas007%,theRSDofpeakareawas155%,andthedetectionlimitwas
0015μg/mL.Thismethodhasgoodsensitivityandsimpleoperation,andcanmeettherequirementsof
mostpharmaceuticalcompaniesforquantitativedetectionofmethylbenzenesulfonate.

Key words: valsartanamlodipinetablets, methylbesylate, highperformanceliquidchromatography,
methodologicalvalidation

CLC Number: