A new HPLC method for the analysis of pregabalin in pharmaceutical preparations

Pregabalin is a drug used as an adjunctive treatment in epilepsy, neuropathic pain, anxiety disorder, social anxiety disorder and partial onset seizures. In this study, a high performance liquid chromatography method was developed for the determination of pregabalin in tablets which does not show sufficient light absorption due to saturated molecular structure. The method is based on the reaction of the primary amine group of Pregabalin with the 9-fluorenylmethyl chloroformate reagent. In this method, the optimum conditions in which the substance reacts with the FMOC reagent are; acetonitrile / water phase ratio of 4: pH: 9 buffer medium at 60 ° C was obtained by heating for 5 minutes. Chromatographic analysis of pregabalin-FMOC derivative was carried out in C18 column with 20 mM potassium phosphate buffer (pH: 3.9) -acetonitrile (70:30, v / v) at a flow rate of 1.0 mL / min. Gabapentin was used as the internal standard and the derivatives were monitored by fluorescence detector at 260 nm excitation and 315 nm emission wavelengths. The linearity range of the substance was 0.5-6.0 μg / mL, the limit of observability and determination were 0.039 μg / mL and 0.117 μg / mL, respectively. The developed method was successfully applied to the analysis of pregabalin in tablets and the results were compared with those obtained by the pharmacopoeia methods by applying Student-t and Fisher-F tests.