Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF PREGABALIN AND AMITRIPTYLINE IN FIXED DOSAGE FORM

M. Devisri*, K. Yamuna, P. Lavanya, Y. Vennela Rani and P. Jayachandra Reddy

ABSTRACT

A simple, accurate, rapid and precise strategy was developed for the simultaneous estimation of Pregabalin and Amitriptyline in fixed dosage form. Chromatogram was run through Inertsil ODS C18 (250 x 4.6 mm, 5) Column. Mobile phase containing Phosphate Buffer (pH 4.5 adjusted with OPA): Methanol taken in the ratio 35:65 was pumped through column at a flow rate of 1 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 215 nm. Retention time of Pregabalin and Amitriptyline were found to be 2.467 min and 4.156 min. respectively. Precision %RSD of Pregabalin and Amitriptyline were found to be 0.5 and 0.8 respectively. % Recovery was obtained in the range of 98-102% for Pregabalin and Amitriptyline respectively. LOD, LOQ values obtained from regression equations of Pregabalin and Amitriptyline were 0.24, 0.72 and 0.08, 0.29 respectively. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Keywords: Pregabalin, Amitriptyline, Validation, RP-HPLC.