Ciprofloxacin Hydrochloride 盐酸环丙沙星质量标准英文

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1、CiprofloxacinHydrochlorideC17H18FN3O3·HCl·H2O385.82Theproductis1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylicacid·hydrochloride·monohydrate.Itcontainsnotlessthan88.5%C17H18FN3O3calculatedontheanhydrousbasis.DescriptionAwhitetoslightlyyellowcrystallinepowder;al

2、mostodourless;bitterintaste.Solubleinwater,slightlysolubleinmethanolorethanol,almostinsolubleinaceticetherormethylenedichloride.Identification(1)DissolveaquantityofCiprofloxacinHydrochlorideandCiprofloxacinHydrochlorideRSinaquantityof0.1mol/LHydrochloridesolutionseparately(every5mgCiprofloxaci

3、nHydrochlorideadd1mlHydrochloridesolution),anddilutethemwithethanoltoobtainatestsolutioncontaining1mgpermlandastandardsolutioncontaining1mgperml.DissolveaquantityofCiprofloxacinHydrochlorideRSandOfloxacinRSinaquantityof0.1mol/LHydrochloridesolutionseparately(every5mgCiprofloxacinHydrochloridea

4、dd1mlHydrochloridesolution),anddilutethemwithethanoltoobtainasystemsuitabilitytestsolutioncontaining1mgCiprofloxacinHydrochlorideand1mgOfloxacinperml.CarryoutthemethodofTLCasdescribedundertheCP(AppendixⅤB)，separatelyapply2mleachofthethreesolutionsabovetoaTLCsilicagelF254plateR,anddevelopthechr

5、omatograminasolventsystemconsistingofamixtureofethylacetate,methanolandconcentratedAmmoniaSolution(5:6:2),untilthesolventfronthasmovedaboutthree-fourthsofthelengthoftheplate.Removetheplatefromthechamberandallowtheplatetoair-dry.Examinetheplateinultravioletlightat254nmor365nm.Thelocationandcolo

6、roftheprincipalbandobtainedfromthetestsolutioncorrespondstothatobtainedfromthestandardsolution.(2)TheretentiontimeofprincipalpeakofthetestsolutionbeingexaminedinthechromatogramobtainedintheAssayisidenticalwiththatofCiprofloxacinHydrochlorideCRS.(3)Theinfraredabsorptionspectrumisconcordantwitht

7、hereferencespectrumofCiprofloxacinHydrochlorideCRS.(4)AsolutionofitrespondstothetestsforChloride(AppendixⅢ).Chooseonefrom(1)and(2).DetectionPHAnaqueoussolutionof25mgperml,PH3.0~4.5(AppendixⅥH).ClarityandcolourofsolutionDissolve1.0gofthe