Simultaneous High Performance Liquid Chromatographic Estimation of AmphotericinB in Dry Injection Dosage Form

J.P. Mall, P.C. Patel And Dr. J.N. Verma

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.

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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