METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ACECLOFENAC AND PREGABALIN IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

A simple, precise, accurate and robust UV Spectroscopic method has been developed for the simultaneous estimation of Aceclofenac and Pregabalin in bulk and tablet dosage forms. In this process the Simultaneous Estimation of the Aceclofenac and Pregabalin was carried out by the simultaneous equation method using Methanol as solvent with 275 nm and 210 nm i.e., λmax of Aceclofenac and Pregabalin respectively. The linearity observed for Aceclofenac was in the range of 2-10μg/ml and for Pregabalin was in the range of 2-10μg/ml. The %RSD for precision for both drugs was <2. The accuracy of methods was assessed by recovery studies and the % recovery was found to be within the range of 98.8-99.72 and 99.3-99.7 for both Aceclofenac and Pregabalin respectively. The developed method was validated with respect to linearity, accuracy (recovery), and precision. LOD and LOQ for Aceclofenac was found to be 0.210µg/ml and 0.638 µg/ml and LOD and LOQ for Pregabalin was found to be 0.1778µg/ml and 0.5388µg/ml respectively. The % Assay was found to be 99.86 and 98.8 for Aceclofenac and Pregabalin respectively. The method was validated as per ICH guidelines and can be employed for simultaneous estimation of both drugs in pharmaceutical formulations with no interference from any other excipients. Keywords: Aceclofenac and Pregabalin, UV-spectroscopy, Methanol.