Abstract :
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.
Keyword :
Pregabalin and RP- HPLC method.