<br/>Gentamicin is a broad spectrum water-soluble antibiotic belonging to the group of aminoglycoside antibiotics. The ratio of major components of gentamicin C, as well as related substances in these commercial products, need to be routinely investigated and controlled. The analysis of gentamicin sulfate in pharmaceutical formulations based on an ion-pairing HPLC-pulsed amperometric detection (PAD) method is described in the U.S. and European Pharmacopoeias (USP and EP). The IonPac AmG-3µm column contains a silica-based packing material used for reversed-phase chromatography but is packed in a polymer (PEEK) column body rather than stainless steel. This column was specifically designed for ion-pairing reversed-phase analysis of aminoglycoside antibiotics. System suitability was evaluated as described in the USP Gentamicin Sulfate monograph using chromatograms of a system suitability standard and 10 µg/mL sisomicin sulfate. The five congeners (C1, C1a, C2, C2a, and C2b) and sisomicin were well separated (Figure 1). Sisomicin is sensitively detected (Figure 2). This study demonstrated that the USP Gentamicin Sulfate monograph Content of Gentamicins method and the USP in-process revision Gentamicin Sulfate monograph method for organic impurities method could be successfully executed with a Dionex IonPac AmG-3µm C18 column using either the 4- or 3-potential carbohydrate PAD waveform. The separation, linearity, reproducibility, and sensitivity were found to meet or exceed the current USP/EP Gentamicin Sulfate monograph performance requirements. This method is reliable and can be used for the routine monitoring of gentamicin.

Determination of gentamicin and related impurities in gentamicin sulfate

256th National Meeting (2018)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.