Quantification of ceftriaxone sodium in pharmaceutical preparations by a new validated microbiological bioassay

摘要

Ceftriaxoneisabroadspectrumantibioticwhichbelongstothethirdgenerationofcephalosporingroup.Asimple,accurate,precise,reproducibleandcosteffectiveonelevelagardiffusion(5+1)bioassaywasdevelopedandvalidatedfortheestimationofpotencyandbioactivityofceftriaxonesodiuminpharmaceuticalpreparations.Among15strainsofbacteriaand3strainsoffungi,KocuriarhizophilaATCC-9341wasselectedasthemosteffectiveorganismagainstceftriaxonesodium.OptimizationofthebioassaywasperformedbyinvestigatingseveralfactorssuchasbufferpH,inoculumsconcentrationandstandardsolutionconcentration.Thedevelopedmethodwassuccessfullyvalidatedwithrespecttolinearity,precisionandaccuracy.ThemeanpotencyrecoveryvalueforceftriaxonesodiumincommercialdrypowderinjectionofMonocefwas100.44%.Anevaluatedvalidationmethodshowedlinearity(r2=0.986),precision(interdayR.S.D=1.03%,betweenanalystR.S.D=1.00%)andaccuracy101.17%(R.S.D=0.80%).IdentificationofMonocefwasperformedbyFTIRspectroscopy.ThepotencyofthemicrobialbioassaywascorrelatedwiththeHPLCmethodusingthesamecommercialsample(Monocef).Theobtainedpercentpotencywas101.39%bytheHPLCmethod.Resultsshowthatthebioassaycanbeapplicableforquantitativedeterminationofthepotencywithbioactivityincommercialformulationsofceftriaxonesodium...