LC-MS-MS METHOD VALIDATION OF PREGABALIN IN HUMAN PLASMA

A rapid, sensitive and specific method for quantification of pregabalin in human plasma using imipramine as internal standard was validated. Sample preparation involved a solid phase extraction procedure. The extract was analyzed by high performance liquid chromatography coupled to electrospray tandem mass spectrometry (LC-MS-MS). Chromatography was performed isocratically on a Hypurity, 5 mu m C-18 (50 x 4.6 mm i.d.), analytical column with buffer-methanol 20:80 (v/v) as mobile phase. The response to pregabalin was a linear function of concentration over the range 250.00 to 20000.00 ng/ml. The lower limit of quantification in plasma was 250.00 ng/ml. The method was successfully applied in a bioequivalence study of a pregabalin formulation after administration single oral dose.