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Abstract: Simple, accurate and reproducible High
Performance Liquid Chromatographic method, requiring no
prior Instrumental methods have been developed for the
estimation of Amphotericin B in Amphotericin B injection
mentioned in I.P.2007,Volume2,Page No.727and728/USP
2007,Volume2,Page No.1410. In both monograph method of
content estimation is determind by Microbiological assay
of Antibiotics.As instrumental analysis is more accurate
as well as less time consuming.
Liquid Chromatographic method for the estimation of
Amphotericin B was developed using Reversed phase
H.P.L.C. having ultra violet detector and separation was
carried out on Column C18(25X4.6mm,5Micron), using Water
486, mode by direct injection.. The retention time for
standard and test was found to be 6.4 minutes.The method
was validated according to ICH guidelines.The method
described is simple, sensitive, reliable and
reproducible for the quantitative estimation of active
ingredient in dosage forms and their levels are found to
be within the ICH limits.
Introduction
AmphotericinB is Antifungal agent, official in Indian
Pharmacopoeia and United State Pharmacopoeia, chemically
it is (3-amino-3,6-di
deoxy-b-D-mannopyranosyloxy)-16-Carboxy-3,5,8,9,11,13,15,35-octahydroxy-34,36-dimethyl-13,17-epoxy-octatviaconta-20,22,24,26,28,30,32-heptaen-37-olide
and other antifungal polyenes produced by the growth of
certain strains of Streptomyces nododus or by any other
means. The review of literature revealed that no
instrumental or chemical method is as yet reported for
the simultaneous estimation of the drugs in dosage
forms. This paper describes simple, rapid, accurate and
reproducible method for determination of drugs in
Injection dosage form.
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