Development and validation of RP- HPLC method for simultaneous estimation of Aceclofenc and Pregabalin in combined tablet dosage form

Objective: A simple accurate, precise, sensitive and reproducible Reverse Phase High Performance Liquid Chromatography method was developed and validated for simultaneous estimation of Aceclofenac and Pregabalin tablet dosage form.Methods: Adequate separation of Aceclofenac and Pregabalin was achieved by BDS Hypersil C18, column using mobile phase containing Phosphate Buffer (pH 4): Methanol (60:40 v/v) at a flow rate of 1.0 ml/min. The analytes were detected at 210 nm. The retention time for Aceclofenac and Pregabalin were obtained as 3.67 min and 6.73 min. respectively.Results: The linearity of Aceclofenac and Pregabalin were found to be in range 25-75 μg/ml and 18.75-56.25 μg/ml (R2=0.9978) respectively. The accuracy of the present method was evaluated at 80%, 100% and 120%. Recovery was found to be in range 99.53-99.57% and 100.34%-100.59% for Aceclofenac and Pregabalin respectively. Intermediate precision studies were carried out and the RSD values were less than two. The method was found to be robust since the retention times and tailing factors were within the limits even after little deliberate variation in flow rate and pH of mobile phase ratio. The value of LOD and LOQ were found to be 25.127 and 76.142 μg/ml for Aceclofenac and 76.142 and 13.739 μg/ml for Pregabalin.Conclusions: This demonstrates that the developed method is simple, precise, accurate and robust for simultaneous estimation of Aceclofenac and Pregabalin in tablet dosage form.