高效液相色谱 - 电喷雾检测硫酸庆大霉素含量

前言：

Develop a rugged HPLC with charged aerosol detection method to separate and detect the gentamicin congeners in gentamicin sulfate drug substance and gentamicin sulfate-containing ointments, solutions, and creams

仪器：Thermo Scientific Dionex UltiMate 3000 Rapid Separation LC

结论：

In this work, a direct-detection reversed-phase HPLC chromatographic assay was developed for gentamicin sulfate. This method uses an Acclaim RSLC PA2 column, which allows the reduction of the concentration of TFA compared to published methods, making the method more suitable for long-term use for both the column and the detector. By using charged aerosol detection, derivatization is not necessary. Three sample matrixes containing gentamicin sulfate were analyzed to determine the content of gentamicin. The quantification of gentamicin base had good recoveries and was consistent with the label claim of these products, both indicators of an accurate assay. This method is faster than previously published methods, with excellent separation between the gentamicin congeners and resolution of many impurities that can be present in fermentation-manufactured products.