Development and validation of HPLC method for the determination of pregabalin in capsules.

A simple, precise, specific, and accurate reverse phase HPLC method has been developed for the determination of pregabalin in capsule dosage form. The chromatography was set on Hypersil BDS, C8, 150×4.6 mm, 5 μm column using photodiode array detector. The mobile phase consisting of phosphate buffer pH 6.9 and acetonitrile in the ratio of 95:05 with flow rate of 1 ml/min. The method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. Lower limit of quantification is 0.6 mg/l. The pregabalin sample solution was found to be stable at room temperature for about 26 h.