Development and validation of HPLC method for the determination of pregabalin in capsules Highly accessed article
Dr. Rafi q Zakaria Campus, Post Graduate Studies and Research Centre, Moulana Azad College Rouza Bagh, Aurangabad-431 00, India
E-mail: [email protected]
A simple, precise, specifi c, 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 fl ow rate of 1 ml/min. The method was validated according to ICH guidelines with respect to specifi city, linearity, accuracy, precision and robustness. Lower limit of quantifi cation is 0.6 mg/l. The pregabalin sample solution was found to be stable at room temperature for about 26 h.