A validated stability indicating RP-HPLC method for simultaneous estimation of paracetamol, aceclofenac and rabeprazole sodium in bulk and combinedtablet dosage form

摘要

To develop a simple, sensitive, specific, precise and accurate stability indicating RP-HPLC method and subsequent validation of the method for the simultaneous estimation of paracetamol, aceclofenac and rabeprazole sodium in bulk and combined tablet dosage form. The chromatographic separation was carried out using waters 2675 HPLC separation module equipped with Agilent CN column (250 X 4.6mm, 5?? particle size) and mobile phase consisting of ammonium acetate buffer (pH adjusted to 7.5 with ammonia solution) and acetonitrile in the ratio of 70:30 % v/v at a flow rate of 1.0 ml/min was used. UV detection was carried out at 213 nm. The retention time of paracetamol, aceclofenac and rabeprazole sodium was found to be 3.678, 5.556 and 9.572 min respectively. The developed method illustrated excellent linearity in the concentration range of 16-488 ??g/ml for paracetamol, 5-150 ??g/ml for aceclofenac and 0.5-16.8 ??g/ml for rabeprazole sodium respectively. Drugs were subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. No chromatographic interference from the tablet excipients was found. The % recoveries were found to be 100.45 % for paracetamol, 100.47 % for aceclofenac and 100.47 % for rabeprazole sodium respectively which shows accuracy of the method. The developed method was validated in accordance with ICH guidelines and was found to be accurate, precise, reproducible and specific and can be successfully applied for the quantitative estimation of paracetamol, aceclofenac and rabeprazole in bulk and pharmaceutical dosage form and in routine quality control analysis.