DEVELOPMENT, VALIDATION & STRESS DEGRADATION STUDIES OF PREGABALIN BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

ABSTRACT: A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the estimation of Pregabalin in pharmaceutical Tablet dosage form. The mobile phase consisted of 50:50 % (v/v) of Methanol & 10mM Ammonium Acetate (pH adjusted to 3.0 with glacial acetic acid) operated on isocratic mode. The flow rate is 0.7 ml/min. Chromatographic determination of Pregabalin was performed on Phenomenex C18 column (150 X 4.6 mm Id, ODS 2, 5µm). The wavelength of detection is 210 nm. The injection volume is 20µL. The retention time of Pregabalin is 3.39 ± 0.10 minutes. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation, solution stability, ruggedness, and robustness. The influence of Acid, Alkaline, Oxidative Stress, Photolytic stress conditions on Pregabalin was studied. Results indicated that pregabalin is stable under the experimental conditions with a hig