NSAIDs are often used for their anti-inflammatory, analgesic, and/or antipyretic effects; it is well known that NSAIDs have the potential to cause gastrointestinal (GI) bleeding through a variety of mechanisms related to their topical and systemic use. Hence the combination of NSAID with a proton pump inhibitor is beneficial for the patients on long term treatment with NSAIDs. An attempt was done to develop simple precise, accurate and validated reverse phase HPLC method for the simultaneous estimation of omeprazole and ketoprofen in bulk and in synthetic mixture using C18 column (Hypersil, 250mm x 4.5 mm) with acetonitrile: 0.02 M potassium dihydrogen phosphate solution (With pH 4.0 adjusted using 1% orthophosphoric acid) (45: 55 v/v) as a mobile phase, at a flow rate of 1.0 ml/min and detection was done at 279.0 nm. The retention time for omeprazole and ketoprofen was found to be 4.06 and 7.03 min, respectively. Linearity of omeprazole and ketoprofen was found in the range of 4-24 μg/ml and 5-30 μg/ml respectively. The percentage assay of omeprazole and ketoprofen was found between 99% to 101%. The statistical parameters were found within range. The result of assay, recovery studies and its statistical validation data indicate high degree of precision and accuracy of the method.
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