Study On The HPLC Analysis Of Gentamicin Components

In this paper, current compendial methods (USP, BP, and EP) for determination of gentamicn C components were fully studied. All of these official methods are problematic for separating or testing the gentamicin C components and related impurities and consequently, the root causes were investigated. Following a comparative study, an improved liquid chromatographic method with integrated pulsed amperometric detection for the analysis of gentamicin components was established and validated using a reversed phase C18 column. In addition to the HPLC-IPAD method, a new aerosol based detector-nano quantity analyte detector, also be explored for the first time to detect the C components of gentamicin, which proved to be a new approach to resolve the great challenge we faced in the analysis of amino glycoside antibiotics.This method, which utilizes a silica based C18 column with pulsed amperometric detection is selective, linear, sensitive and robust, and could separate and detect more than ten impurities of gentamicin apart form the five major components. It is a suitable alternative to the official method for the analysis C components of gentamicin and related impurities as well.NQAD shares the same mechanism of nebulization and evaporation with ELSD, however, it has different detecting way result in a linear detection curve and two order of magnitude more sensitive than ELSD.By employing the IPAD and NQAD detecting technologies, some problems existing in the analysis of gentamicin were effectively solved, and a new perspective for the quality control of aminoglycoside antibiotics was provided.