DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF CELECOXIB AND PARACETAMOL IN ITS BULK AND TABLET DOSAGE FORM

The present study describes the development and validation of a simple, accurate, and precise Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of Celecoxib and Paracetamol in bulk and pharmaceutical tablet dosage forms. Chromatographic separation was achieved using a Phenomenex Luna C18 column (4.6 × 150 mm, 5.0 µm) with a mobile phase of Methanol: Water (70:30 v/v) at a flow rate of 1 ml/min. Detection was performed at 260 nm, with an injection volume of 10 µl and a run time of 14 minutes under ambient temperature. Both drugs were well resolved with sharp, symmetrical peaks, and the method was validated in accordance with ICH guidelines. The results confirmed the method to be linear, accurate, precise, specific, robust, and sensitive. Recovery studies showed values close to 100%, indicating accuracy, while %RSD values within acceptable limits demonstrated reproducibility. The method successfully estimated the active pharmaceutical ingredients without interference from excipients. This validated RP-HPLC method can be effectively applied for the routine quality control and analysis of Celecoxib and Paracetamol in bulk drugs as well as in their combined tablet formulations. Keywords: RP-HPLC, Celecoxib, Paracetamol, Phenomenex Luna C18, simultaneous estimation, validation.