A sensitive, simple and selective spectrofluorimetric method was developed for the determination of Pregabalin in pharmaceutical formulation and in biological fluids. The method is based on the reaction between the drug and 1-dimethylaminonaphthalene- 5-sulphonyl chloride in the presence of mixture (acetone: 0.5 M sodium carbonate, 3:1) at pH 9.8 to yield a highly fluorescent derivative that is measured at 440 nm after excitation at 332 nm. Different experimental parameters affecting the development and stability of the reaction product were carefully studied and optimized. The fluorescence concentration plot was rectilinear over the range of 0.04 – 0.24 µg/ml with a lower detection limit (LOD) of 0.01 µg/ml and the limit of quantitation (LOQ) of 0.04 µg/ml. The proposed method was successfully applied to the analysis of commercial tablets. Furthermore, the method was applied for the determination of Pregabalin in spiked human plasma, the mean % recovery (n = 5) is 97.82 ± 0.373. A proposal of the reaction pathway was also presented.
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