头孢拉定胶囊英国药典BP2013 UpdatedB

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1、·BritishPharmacopoeiaVolumeIII·FormulatedPreparations:SpecificMonographsCefradineCapsulesGeneralNoticesActionanduseCephalosporinantibacterial.DEFINITIONCefradineCapsulescontainCefradine.ThecapsulescomplywiththerequirementsstatedunderCapsulesandwiththefol

2、lowingrequirements.Contentofcephalosporins,calculatedasthesumofcefradine(C16H19N3O4S),cefalexin(C16H17N3O4S)and4′,5′-dihydrocefradine(C16H21N3O4S)90.0 to105.0%ofthestatedamountofCefradine.IDENTIFICATIONA.Theinfraredabsorptionspectrumofthecontentsofthecap

3、sules,AppendixIIA,isconcordantwiththereferencespectrumofcefradine(RS050).Ifthespectraarenotconcordant,dissolveaquantityofthecapsulecontentscontaining30 mgofCefradinein10 mLofmethanol,evaporatetodrynessat40°atapressureof2 kPaandprepareanewspectrum.B.Carry

4、outthemethodforthin-layerchromatography,AppendixIIIA,usingthefollowingsolutions.(1)Shakeaquantityofthecontentsofthecapsulescontaining0.1 gofCefradinewith25 mLof0.01Mammoniafor45 minutesanddilute1 mLoftheresultingsolutionto10 mLwith0.01Mammonia.(2)0.040%w

5、/vofcefradineBPCRSin0.01Mammonia.CHROMATOGRAPHICCONDITIONS(a)UseaTLCsilicagelplate(Analtechplatesaresuitable).Impregnatetheplatebyplacingitinatankcontainingashallowlayerofa5%v/vsolutionofn-tetradecaneinn-hexane,allowingtheimpregnatingsolventtoascendtothe

6、top,removingtheplatefromthetankandallowingthesolventtoevaporate;usewiththeflowofthemobilephaseinthesamedirectionthattheimpregnationwascarriedout.(b)Usethemobilephaseasdescribedbelow.(c)Apply5 µLofeachsolution.(d)Developtheplateto15cm.(e)Afterremovalofthe

7、plate,heatat90°for2 to3 minutesandspraythehotplatewitha0.1%w/vsolutionofninhydrininthemobilephase.Heatat90°for15 minutesinacirculatingairovenwiththeplatesparalleltotheairflow,coolfor15 minutesprotectedfromlightandexamineindaylight.MOBILEPHASE3 volumeofac

8、etone,80 volumesof0.2Manhydrousdisodiumhydrogenorthophosphateand120 volumesof0.1Mcitricacid.CONFIRMATIONTheprincipalspotinthechromatogramobtainedwithsolution(1)correspondstothatinthechromatogramobtainedwithsolution(2).TEST