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A high-performance liquid chromatographic method for the determination and control of the composition of gentamicin sulphate
Authors:K. Kraisintu  R.T. Parfitt  M.G. Rowan
Affiliation:School of Pharmacy and Pharmacology, University of Bath, Claverton Down, Bath BA2 7AY U.K.
Abstract:A high-performance liquid chromatographic method for routine control of the composition of gentamicin sulphate is described. The method utilizes pre-column derivatization followed by reversed-phase chromatography with fluorescence detection and uses an internal standard for quantification. Analysis of 19 samples of gentamicin from various sources indicates that the ratio of the major components and the content of minor constituents varies with the geographical origin of the sample. The results were compared with those of a microbiological assay and the B.P. nuclear magnetic resonance (nmr) spectroscopic limit test of the same samples. The microbiological assay may be influenced by biologically active impurities whilst the nmr assay was insensitive to the presence of minor components. The method described offers a more discriminating and flexible means of monitoring the composition of gentamicin and hence of providing data upon which a realistic specification for this valuable antibiotic mixture can be prepared.
Keywords:To whom correspondence should be addressed at his present address: Faculty of Pharmacy   University of Alexandria   Alexandria   Egypt.
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