Development and Validation of Stability Indicating UPLC-PDA/MS for the Determination of Imiquimod and its Eight Related Substances: Application to Topical Cream.

A stability indicating analytical method for imiquimod and its related impurities was developed by ultra-pressure liquid chromatography (UPLC) using design of experiments. This method could quantify imiquimod and all its eight known related impurities in a single run. The optimum separation was achieved on reverse phase Acquity UPLC column (2.