头孢拉定胶囊英国药典bp2013updatedb

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1、BritishPharmacopoeiaVolumeIIIFormulatedPreparations:SpecificMonographsCefradineCapsulesGeneralNoticesActionanduseCephalosporinantibacterial.DEFINITIONCefradineCapsulescontainCefradine.ThecapsulescomplywiththerequirementsstatedunderCapsulesandwiththefollowingrequirements・Con

2、tentofcephalosporins,calculatedasthesumofcefradine(C16H19N3O4S),cefalexin(C16H17N3O4S)and4',5'・dihydrocefradine(C16H21N3O4S)90.0to105.0%ofthestatedamountofCefradine.IDENTIFICATIONA.Theinfraredabsorptionspectrumofthecontentsofthecapsules,AppendixIIA,isconcordantwiththerefere

3、ncespectrumofcefradine(RS050).Ifthespectraarenotconcordant,dissolveaquantityofthecapsulecontentscontaining30mgofCefradinein10mLofmethanol,evaporatetodrynessat40°atapressureof2kPaandprepareanewspectrum.B.Carryoutthemethodforthimlayerchromatoqraphy,AppendixIIIA,usingthefollow

4、ingsolutions.(1)Shakeaquantityofthecontentsofthecapsulescontaining0.1gofCefradinewith25mLof0.01mammoniafor45minutesanddilute1mLoftheresultingsolutionto10mLwith0.01mammonia.(2)0.040%w/vofcefradineBPCRSin0.01mammoniaCHROMATOGRAPHICCONDITIONS(a)UseaTLCsilicagelplate(Analtechpl

5、atesaresuitable).Impregnatetheplatebyplacingitinatankcontainingashallowlayerofa5%v/vsolutionofn-tetradecaneinn-hexane,allowingtheimpregnatingsolventtoascendtothetop,removingtheplatefromthetankandallowingthesolventtoevaporate;usewiththeflowofthemobilephaseinthesamedirectiont

6、hattheimpregnationwascarriedout.(b)Usethemobilephaseasdescribedbelow.(c)Apply5pLofeachsolution.(d)Developtheplateto15cm.(e)Afterremovaloftheplate,heatat90°for2to3minutesandspraythehotplatewitha0.1%w/vsolutionofninhydrinjnthemobilephase.Heatat90°for15minutesinacirculatingair

7、ovenwiththeplatesparalleltotheairflow,coolfor15minutesprotectedfromlightandexamineindaylight.MOBILEPHASE3volumeofacetone、80volumesof0.2manhydrousdisodiumhydrogenorthophosphateand120volumesof0.1mcitricacid.CONFIRMATIONTheprincipalspotinthechromatogramobtainedwithsolution(1)c

8、orrespondstothatinthechromatogramobtainedwithsolution(2).TESTSDissolutionComplywit