title: Electrochemical detection of tobramycin or gentamicin according to the European Pharmacopoeia analytical method.
abstract: Tobramycin and gentamicin are two aminoglycosidic antibiotics used in lung infection, ophthalmic treatments as well as in skin infections. Pharmaceutical companies which produce remedies containing tobramycin and gentamicin need an analytical method for their internal quality control. For several years a simple chromatographic method based on anion exchange separation coupled with amperometric detection was proposed for aminoglycosides. This analytical approach was partially used in the last edition of the European Pharmacopoeia (EP) for tobramycin and gentamicin analysis. In fact they use integrated pulsed amperometric detection (IPAD) on a gold electrode while the separation is obtained on a polymeric wide pore reversed phase instead of anion exchange in alkaline conditions. Such coupling seems to be cumbersome and not so easy to realize and to reproduce from one laboratory to another. Besides, the described method lacks some of the details as important as the waveform steps duration. Unfortunately the quality control (QC) laboratories have to use exactly the method described in the EP, so they complained about the troubles. Therefore, the EP authors published recently a paper regarding the guidelines for good practice in the method application, but the suggestion was not yet resolutive. In our work we evaluated the eluent composition and the kind of amperometric cell, work electrode diameter and cell volume. Mainly we optimized the amperometric waveform. In addition, for tobramycin analysis another chromatographic phase was explored in order to achieve better efficiency and to separate all the impurities confirming the effectiveness of the detection. The conditions described in the paper seem to allow the analyst to operate in conformity with the EP method.
authors.affiliation: Manufacturing Logistic and Services srl, Via Rosolino Pilo 4, Firenze, Italy. c_ghinami@yahoo.it
authors.forename: C
authors.initials: C
authors.lastname: Ghinami
authors.forename: V
authors.initials: V
authors.lastname: Giuliani
authors.forename: A
authors.initials: A
authors.lastname: Menarini
authors.forename: F
authors.initials: F
authors.lastname: Abballe
authors.forename: S
authors.initials: S
authors.lastname: Travaini
authors.forename: T
authors.initials: T
authors.lastname: Ladisa
mesh_terms: D000617:Aminoglycosides / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004563:Electrochemistry / Q000379:methods*; D005060:Europe; D005839:Gentamicins / Q000032:analysis*; D010602:Pharmacopoeias as Topic / Q000592:standards*; D011786:Quality Control; D014031:Tobramycin / Q000032:analysis*
chemical_list: D000617:Aminoglycosides; D005839:Gentamicins; D014031:Tobramycin