ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF OMEPRAZOLE AND ASPIRIN USING REVERSE PHASE HPLC METHOD IN BULK AND DOSAGE FORM

Abstract

Objectives: A new simple, accurate, precise and reproducible RP-HPLC method has been developed for the simultaneous estimation of Aspirin and Omeprazole in bulk and pharmaceutical dosage form using C18 column (Agilent, 250 x 4.6 mm, 5μm) in isocratic mode. Methods: The mobile phase consisted of Methanol and 0.1 M Di-potassium Phosphate buffer (pH 3) in the ratio of 60:40 v/v. The detection was carried out at 256 nm. The method was linear over the concentration range for Omeprazole 50-250 μg/ml and for Aspirin 10-50μg/ml. Results: The recoveries of Omeprazole and Aspirin were found to be 100.07 and 100.06% respectively. The validation of method was carried out utilizing ICH-guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. Conclusion: Study concludes that the proposed method is accurate, precise, rapid and selective has advantage of simplicity and convenience for the separation and quantitation of ASP and OMP in the combination which can be used for the assay of their dosage form. Cite this article-R Vani, M Sunitha. Analytical method development and validation for the determination of Omeprazole and Aspirin using reverse phase HPLC method in bulk and dosage form.