METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING ASSAY PROCEDURE OF PREGABALIN BY USING RP-HPLC

A simple, rapid and precise Reverse phase liquid chromatographic method has been developed and subsequently validated for estimation of Pregabalin in tablet dosage form. The method is based on High Performance Liquid Chromatography (HPLC) on a reversed-phase column. The separation was carried out using a mobile phase consisting of Phosphate buffer of pH 6.2 and acetonitrile (70:30 v/v). The column used was reversed-phase, Develosil C18, (5µm, 150 x 4.6 mm i.d. column) with flow rate of 1.0 ml/min, column temperature at 40°C using UV detection at 225 nm. The drug was well resolved on the stationary phase and the retention times were around 2.33 minute. The method was validated and shown to be linear for Pregabalin. The correlation coefficient for Pregabalin is 0.998. The relative standard deviations for five replicate measurements in two sets of each drug in the tablets is always less than 2% and mean % error of active recovery not more than ±1.5%. Pregabalin was subjected to various degradation conditions like acidic, alkaline, thermal, oxidation, photo, UV degradation and neutral conditions for a period of 24 hrs and it was found to degrade to different extent in different conditions. Pregabalin was found to be highly degraded at oxidation and photo degradation and comparatively stable under neutral condition. The method was validated for precision and accuracy. The proposed method was successfully applied to the pharmaceutical dosage forms containing the above mentioned drug without any interference by the excipients. Keywords: Pregabalin and RP- HPLC method.