SIMULTANEOUS DETERMINATION OF OMEPRAZOLE AND DOMPERIDONE IN CAPSULES AND IN VITRO DISSOLUTION STUDIES BY USING STABILITY INDICATING UPLC

Abstract

A novel stability indicating UPLC method was developed and validated for the simultaneous determination of omeprazole and domperidone in capsules formulation. The analysis was performed on a waters Acquity UPLC system with an Acquity UPLC BEH C18 column (5 mm × 2.1 mm I.D., 1.7 µm). Isocratic elution with a mobile phase consisting of a mixture of phosphate buffer (pH 5.0, 0.05 M) and Acetonitrile in the ratio of 68:32 (v/v). The flow rate was 0.4 mL/min and the column temperature maitained at 50°C. The eluted compounds were monitored at 285 nm. Total run time was 2 min within which the two compounds were well-seperated. Stability indicating capability was established by forced degradation experiments and seperation of known impurities from the two compounds. The method was validated for accuracy, precision, specificity, and linearity and hence the method was concluded to be stability indicating. The method is also applicable for analysis of Assay and also for study of in vitro dissolution profiles.