葡萄糖定溶液药典药大生药学0658e.pdfVIP

ChlorhexidinedigluconatesolutionEUROPEANPHARMACOPOEIA7.0

hydrochloricacidRand20mLofdilutehydrochloricacidR

insteadofthesolutionofthesubstancetobeexamined.

Relatedsubstances.Liquidchromatography(2.2.29).

Testsolution.Dissolve0.200gofthesubstancetobeexamined

inthemobilephaseanddiluteto100mLwiththemobilephase.

Referencesolution(a).Dissolve15mgofchlorhexidine

forperformancetestCRSinthemobilephaseanddiluteto

10.0mLwiththemobilephase.B.[[6-[[[(4-chlorophenyl)carbamimidoyl]carbamimidoyl]-

amino]hexyl]carbamimidoyl]urea,

Referencesolution(b).Dilute2.5mLofthetestsolutionto

100mLwiththemobilephase.

Referencesolution(c).Dilute2.0mLofreferencesolution(b)

to10mLwiththemobilephase.Dilute1.0mLofthissolution

to10mLwiththemobilephase.

Column:

—size:l=0.2m,Ø=4mm;

—stationaryphase:octadecylsilylsilicagelforC.1,1′-[hexane-1,6-diylbis(iminocarbonimidoyl)]bis[3-(4-

chromatographyR(5μm).chlorophenyl)urea],

Mobilephase:solutionof2.0gofsodiumoctanesulfonateRin

amixtureof120mLofglacialaceticacidR,270mLofwaterR

and730mLofmethanolR.

Flowrate:1.0mL/min.

Detection:spectrophotometerat254nm.

Equilibration:withthemobilephaseforatleast1h.

Injection:10μL.

Runtime:6timestheretentiontimeofchlorhexidine.

Systemsuitability:referencesolution(a):

D.1,1′-[[[[(4-chlorophenyl)carbamimidoyl]imino]methylene]-

—thechromatogramobtainedissimilartothechromatogram