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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Abstract: Abstract:Themethodfordeterminationofmethylbenzenesulfonateinvalsartanamlodipinetabletswas validated.GradientelutionwasperformedonAgelaVenusilXBPC18(L)column(46×150mm, 5μm,150A)with1% triethylaminephosphatebuffer(pH=28)-acetonitrileasmobilephase.The detectionwavelengthwas216nm,thecolumntemperaturewas40℃,theflowratewas10mL/min, thesamplevolumewas50μL,thesolventwasacetonitrilewater(50∶50),andthecontentofmethyl benzenesulfonateinValsartanamlodipinetabletswasdetermined.Thedetectedamountofmethylbenze nesulfonateshallnotexceed43ppmaccordingtothepeakareacalculationbyexternalstandardmethod. Itwasfoundthatmethylbenzosulfonatehadagoodlinearrelationshipintheconcentrationrangeof0049 ~055μg/mL(limit10~77mg/L)(r=09998).Thelimitofquantificationwas0049μg/mL, theRSDofretentiontimewas007%,theRSDofpeakareawas155%,andthedetectionlimitwas 0015μg/mL.Thismethodhasgoodsensitivityandsimpleoperation,andcanmeettherequirementsof mostpharmaceuticalcompaniesforquantitativedetectionofmethylbenzenesulfonate.
Key words: valsartanamlodipinetablets, methylbesylate, highperformanceliquidchromatography, methodologicalvalidation
CLC Number:
R917
ZHAOJiang, ZHANGZhuoxi. ValidationofMethodologyforDeterminationofMethylBenzenesulfonate#br# ImpuritiesinValsartanAmlodipineTabletsbyHPLC#br#[J]. Journal of Kunming Metallurgy College, 2024, 40(6): 34-.
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URL: http://kmyzxb.magtech.com.cn/EN/doi:10.3969/j.issn.1009-0479.2024.06.006
http://kmyzxb.magtech.com.cn/EN/Y2024/V40/I6/34