STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF PREGABALIN IN PHARMACEUTICAL DOSAGE FORMS BY RP - HPLC

A simple, pre cise, accurate, reproducible Stability indicating RP - HPLC method was developed for the determination o f Pregabalin in pharmaceutical dosage forms. After optimization chromatographic separation was achieved by Isocratic mode with a mixture of dipotassium hydrogen phosphate: methanol in the ratio of 60:40% v/v as the mobile phase with AGILENT ZORBAX SB - ODS C18 ( 250 × 4.6 mm I.D) 5 μm column as stationary phase at flow rate of 1 mL/min and detection wavelength of 247 nm. The retention time for Pregabalin found to be 2.00 min respectively. The linearity of this method was found in the concentration range of 50 μg/mL to 150 μg/mL for pregabalin . The correlation coefficient R 2 value is found to be 0.99 for Pregabalin . The LOD and LOQ for pregabalin were found to be 0.53 μg/mL and 1.61 μg/mL respectively. Percentage recovery for pregabalin were found to be 1 00% which indicates that the proposed method is highly accurate. The drug was subjected to acid hydrolysis, base hydrolysis, peroxide, heat and sunlight degradation and the method was found to be specific and stability indicating as no interfering peaks of degradants and excipients were observed. Keywords: Pregabalin , RP - HPLC, Dosage form, Stability indicating