Ion chromatographic method for rapid and quantitative determination of tromethamine

Tromethamine is commonly used as a buffering agent, alkalizer, and emulsifying agent in pharmaceutical and cosmetic preparations and as a counterion for acidic drug substances. Methods reported in the literature for the determination of tromethamine have typically been non-specific or required derivatization and are not suitable for quantitative analysis in a dosage form or drug substance matrix. An ion chromatographic method with conductivity detection was employed to provide rapid and quantitative determination of tromethamine in these matrices. The method was found to be specific with regard to drug substance and dosage form components. The method was validated and found to provide suitable linearity, accuracy and precision for use as a pharmaceutical assay method.