DEVELOPMENT, VALIDATION & STRESS DEGRADATION STUDIES OF PREGABALIN BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHYAbstract
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 high baseline noise observed in alkaline medium. The proposed method has been successfully used for the estimation in tablet dosage forms.
K. Siva Nagaraju , Battula Sreenivasa Rao* and B.V. Kiran
Associate Professor, Department of Chemistry, GIT, Gitam University, Visakhapatnam, Andhra Pradesh, India
16 March, 2013
09 June, 2013
29 June, 2013
01 July, 2013