To develop an UPLC method for phenylephrine- and pseudoephedrine-containing formulations utilizing a new column chemistry for polar retention.
Standards of common cold and allergy medicine active ingredients and published degradants/impurities were combined into one mixture to cover all possible formulation compositions. Using the ACQUITY UPLC system and MS/MS and UV detection, various separations were developed on a new UPLC column chemistry designed to enhance the retention of polar analytes.
Gradient separations were 10 minutes or less, depending on the amount of resolution required. Detection limits for the impurities/degradants were well below the 0.1% threshold.
Stability indicating-type separations for phenylephrine containing formulations were achieved using the new polar retention phase for UPLC.