Development and validation of HPLC method for the determination of pregabalin in bulk and in pharmaceutical formulations

Pregabalin, a α-amino-n-butyric acid derivative, is an antiepileptic drug which is not yet official in any pharmacopoeia. Thus, the development of analytical procedures for this drug in bulk/formulation form is need of the day. We, herein, report a new, simple, specific, accurate, cost effective and reproducible spectrophotometric method for the determination of pregabalin. The chromatography was set on Kromasil, C18, 100 x 4.6mm, 5 μm column using UV detector. The mobile phase consitituted of phosphate buffer pH 6.9 and acetonitrile in the ratio of 90:10 with the flow rate of 1ml/min. The method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. Also, the developed method was successfully applied to determination of pregabalin in pharmaceutical formulations without any interference from common excipients. Hence, this method can be very useful for routine laboratory analysis of pregabalin.