ION-CHROMATOGRAPHIC METHOD FOR RAPID AND QUANTITATIVE-DETERMINATION OF TROMETHAMINE

Tromethamine is commonly used as a buffering agent, alkalizer, and emu lsifying agent in pharmaceutical and cosmetic preparations and as a co unterion for acidic drug substances. Methods reported in the literatur e for the determination of tromethamine have typically been non-specif ic or required derivatization and are not suitable for quantitative an alysis in a dosage form or drug substance matrix. An ion chromatograph ic method with conductivity detection was employed to provide rapid an d quantitative determination of tromethamine in these matrices. The me thod was found to be specific with regard to drug substance and dosage form components. The method was validated and found to provide suitab le linearity, accuracy and precision for use as a pharmaceutical assay method.