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Abstract

NEW COST EFFECTIVE STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ASPIRIN AND OMEPRAZOLE IN THE BULK DRUG AND SYNTHETIC MIXTURE

Amit Kumar Jain* Dr. B. K. Dubey, Deepak Basedia, Salaj Khare, Suresh Dhakar, Om Prakash

Technocrats Institute of Technology- Pharmacy Education & Research, Bhopal (M.P.).

ABSTRACT

A novel stability-indicating RP-HPLC method has been developed and validated for the simultaneous estimation of Aspirin and Omeprazole in bulk and synthetic mixture. An isocratic separation of Aspirin and Omeprazole was achieved on Thermo C₁₈ column (4.6 x 250mm, 5μ particle size) as the stationary phase with a flow rate of 1.0 ml/min and using a UV detector to monitor the eluate at 295nm. The mobile phase consisted of acetonitrile: phosphate buffer pH-6 (70:30v/v) enabled separation of the drug from its degradation products. The method was validated for linearity, accuracy (recovery), precision and specificity. The linearity of the method was satisfactory over the range 5–25 μg/ml (correlation coefficient 0.9997) for both the drugs. The limits of detection and quantification for Aspirin and Omeprazole were 0.89, 2.41 and 0.45, 1.25 μg/ml respectively. The recoveries of Omeprazole and Aspirin from synthetic mixture were found to be 100.07 and 100.06% respectively. Aspirin and Omeprazole was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis, and thermal degradation) and the samples were analyzed by this method. Both substances were unstable in basic conditions. The drug was stable under the other stress conditions investigated. The degradation products were well resolved from main peak. The forced degradation study prove the stability indicating power of the method and therefore, the validated method may be useful for routine analysis of Aspirin and Omeprazole as bulk drug, in respective dosage forms, for dissolution studies and as stability indicating assay method in pharmaceutical laboratories and industries.

Keywords: Aspirin, Omeprazole, RP-HPLC, forced degradation, method validation.


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