Determination of meglumine in pharmaceutical formulations using high performance liquid chromatography.

Four different approaches were followed for the development of a HPLC method for the determination of meglumine in solid dosage formulations: derivatization of meglumine prior to HPLC analysis, the use of an ion-pairing reagent in the mobile phase, the use of charged surface hybrid stationary phase and the use of a column designed for carbohydrate separations. The method using anionic pairing reagent in the mobile phase was shown to be suitable for the quantitative determination of meglumine in solid dosage forms. The HPLC separation was achieved on an Agilent Eclipse XDB-C18 column (150 mm x 4.6 mm, 3.5 microm particle size) using a mobile phase with octane-1-sulfonic acid. The method was validated and validation included the following studies: selectivity, precision (repeatability), linearity and accuracy. During validation experiments RID and DAD detectors were used.