DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TAPENTADOL HCL, ACECLOFENAC AND PARACETAMOL IN TERNARY MIXTURE

Objective: To develop a accurate, precise and specific RP-HPLC method for simultaneous estimation of Tapentadol HCl (TAP), Aceclofenac (ACE) and Paracetamol (PCM) in its laboratory synthetic mixture. Methods: The optimized method uses C8 Thermo quest, hypersil division, 250*4.60 mm; 5 μ column, mobile phase consisting of phosphate buffer (pH 3) and acetonitrile in the ratio of 40:60, flow rate 0.8 ml/min. The detection wavelength was set at 217 nm. Results: The developed method resulted Paracetamol, Tapentadol HCl and Aceclofenac in eluting at 4.008 min 4.595 min and 6.073 min respectively. Linearity was observed over the concentration range of 52-130 µg/ml for PCM, 16-40 µg/ml forACE and 12-30 µg/ml forTAP. The percentage recovery was found to be in the range of 98-102% at three different levels of a standard addition. The precision (intra-day, inter-day) of the method was within the limit (RSD<2%). Conclusion: The proposed method was found to be accurate, precise, reproducible and specific and it can be used for qualitative and quantitative determination of Tapentadol HCl, Aceclofenac and Paracetamol in their combined dosage form in the pharmaceutical industry.