Development and Validation of HPLC Method for Estimation of Pregabalin in Bulk & Capsule Dosage Form

Abstract

A simple, rapid, specific, precise and accurate HPLC method has been developed for the estimation of Pregabalin in bulk drugs and in capsule dosage forms. The mobile phase consisted of 80: 10: 10 (v/v/v) of Disodium Hydrogen Phosphate Buffer: Acetonitrile: Methanol. The flow rate is 1 ml/min. Chromatographic determination of Pregabalin was performed on Inertsil ODS-3V, C18 (250 X 4.6 mm Id, 5μm) column. The wavelength of detection is 210 nm. The injection volume is 20μL. The retention time of Pregabalin is 4.7 minutes. The developed method was validated in terms of specificity, accuracy, precision, linearity, solution stability, ruggedness, robustness and system suitability. The influence of Acid, Alkaline, Oxidative Stress, Photolytic stress, Thermal stress, and Humidity stress conditions on pregabalin was studied. Results indicated that Pregabalin is stable under the experimental conditions. The proposed method has been successfully used for the routine analysis of pregabalin in capsule dosage forms.