Analysis of magnesium from magnesium stearate in pharmaceutical tablet formulations using hydrophilic interaction liquid chromatography with nano quantity analyte detection

摘要

This study demonstrates the use of hydrophilic interaction liquid chromatography with a nano quantity analyte detector for the retention, separation and detection of magnesium from magnesium stearate in tablet formulations for a drug product formulation blend containing a hydrochloride salt of a weakly basic compound as the active ingredient. The nano quantity analyte detector can provide direct detection of inactive excipients and inorganic salts lacking ultraviolet chromophores, as well as, all non-volatile compounds. The separation was accomplished using a SeQuant ZIC?-HILIC column and mobile phase consisting of 32.5:32.5:35 of acetone/methanol/ammonium formate buffer (150mM, pH 4.5). Common validation parameters were evaluated to assess the method's quantitative potential for magnesium (from magnesium stearate) including: linearity, accuracy, specificity, solution stability, repeatability, and intermediate precision. Overall, the method described in this report proved to be very robust and represents a novel technique to conveniently separate and detect magnesium from magnesium stearate in pharmaceutical preparations both quickly and accurately.