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EnantiomericSeparationofMoxifloxacinandIts(R,R)-IsomerbyLigand-ExchangeChiralChromatography2009,69,85–89&M.Ravikumar1,,M.SatishVarma1,T.SatyanarayanaRaju1,P.Suchitra2,P.YadagiriSwamy11DepartmentofChemistry,UniversityCollegeofEngineering,OsmaniaUniversity,Hyderabad500007,India;E-Mail:ravi20737@yahoo.com2MatrixLaboratoriesLimited,ICICIKnowledgePark,Turkapally,ShameerpetMandal,R.R.Dist.,Hyderabad,AndhraPradesh500078,IndiaReceived:21June2008/Revised:20August2008/Accepted:3September2008Onlinepublication:26October2008IntroductionAbstractMoxifloxacinhydrochloridebelongstothefluoroquinoloneclassofanti-infectiveAnewstereospecificLCmethodfortheseparationandquantificationofmoxifloxacinanditscompounds.Thecompoundhasabroad(R,R)-enantiomerinbulkdrugwasdevelopedandvalidatedbyligand-exchangeliquidantibacterialspectrumagainstGram-chromatographyonareversedphasecolumnusingaqueousmobilephasecontainingthepositiveandGram-negativeorganismschiralreagentL-isoleucine-Cu(II).TheUVdetectorwasoperatedat293nm.Theflowrateofincludinganaerobicbacteriaandwasmobilephasewassetat0.9mLmin-1.TheachiralODScolumnoffersgoodseparationofdevelopedbyscientistsatBayerAGforthetwoenantiomersinlessthan20min.Thetestconcentrationwas1,000lgmL-1inthesystemictreatmentsofrespiratorytractmobilephase.Thismethodwascapableofdetectingthe(R,R)-enantiomerofmoxifloxacinupinfections[1].to0.1lgmL-1fora20lLinjectionvolume.ThedrugwassubjectedtostressconditionsofMoxifloxacinisproducedasasinglehydrolysis,oxidation,photolysisandthermaldegradation.Therewasnointerferenceofisomerandan(R,R)-isomercouldbedegradantswiththe(R,R)-enantiomerinthedevelopedmethod.ThedevelopedchiralRP-LCpresentasachiralimpurity(Fig.1).methodwasvalidatedwithrespecttolinearity,accuracy,precisionandrobustness.TheThereisnoreferenceintheliteratureforpercentagerecoveryforthe(R,R)-enantiomerinbulkdrugsamplesrangedfrom98.1totheenantiomericseparationofmoxi-104.4%.Thetestsolutionwasfoundtobestableinthemobilephasefor48hafterprep-floxacininthebulkdrugs
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