For the determination of Pregabalin in tablet formulation, a simple, precise, and accurate stability-indicating reversed-phase HPLC method has been established for the estimation of Pregabalin in bulk and tablet formulation. The chromatographic separation was achieved by a mobile solvent system having a buffer (pH 6.5, sodium chloride) and methanol in the proportion (55:45) v/v, wavelength 210 nm, flow rate 1.0 ml per min. Pregabalin had an RT of 2.022 min. The calibration curve was linear in the range of 45-120 µg/ml with a correlation coefficient of 0.9998. Relative standard deviation values for all key parameters was less than 2.0%. The percentage recovery was found to be 99.86%. The developed method was validated as per ICH guidelines for specificity, linearity, accuracy, precision, and system suitability. Further, the proposed method was found to be reproducible and convenient for stability-indicating analysis of Pregabalin in marketed bulk and tablet dosage form.

Keywords: Pregabalin, Reversed-Phase, HPLC, Validation, ICH recommendations