“Analytical Method Development and Validation of Pregabalin by RP-HPLC Method”

Abstract

A simple, precise, reproducible Reverse Phase High-Performance Liquid Chromatography method was developed and validated for Pregabalin in the capsule dosage form. Chromatographic separation was achieved by Kromasil C18, (250 mm x 4.6 ID, Particle size- 5 microns) column and Acetonitrile: 0.1% TFAA (15:85 %V/V) as mobile phase, at a flow rate of 1 ml/min (milliliter per minute) Using UV detection at 210nm. The method has been validated for linearity, accuracy, precision, LOD, and LOQ. The linearity of Pregabalin was found to be in the range of 50.0 - 750.0 µg/mL. (R2=0.99992) respectively. The accuracy of the present method was evaluated at 50%, 100%, and 150%.  Recovery was found to be in a range from 99.06-99.60.  Values of LOD (11.572 µg/ml for PRE) and LOQ (35.068 µg/ml for PRE) indicated good sensitivity of the method. Pregabalin was estimated precisely and accurately using the proposed analytical method, which was validated under ICH requirements.