SIMULTANEOUS DETERMINATION OF ILAPRAZOLE AND ITS RELATED COMPOUNDS IN PHARMACEUTICAL DOSAGE FORMS BY UPLC

A stability indicating UPLC method was developed and validated for simultaneous determination of Ilaprazole and its impurities in tablets. The chromatographic separation was performed on an Acquity BEH SHIELD RP18 column (1.7 mu m, 2.1mmx150mm) by adopting gradient elution using acetonitrile:methanol and ammonium acetate buffer (0.05M; pH 8.5 adjusted with NaOH solution) at 40 degrees C with the flow rate of 0.25mL/min. UV detection was performed at 305nm. Total run time was 12min for performing the analysis in which a main compound; five known and other unknown impurities were separated. The method was suitably validated with respect to linearity, limit of detection, limit of quantification, accuracy, precision, and selectivity. The calibration curves obtained for the five impurities were linear over the range 0.05 to 0.60 mu g/mL. The relative standard deviations of intra- and inter-day experiments were less than 3.0%. The detection limits ranged from 0.015 to 0.021 mu g/mL depending on the impurity.