Akademik Veri Yönetim Sistemi
PHARMACEUTICAL CHEMISTRY JOURNAL, cilt.59, sa.2, ss.216-221, 2025 (SCI-Expanded)
A high-performance liquid chromatography method was developed and validated for the determination of pregabalin in tablets in this study. Since pregabalin does not show sufficient light absorption because of its saturated molecular structure, analysis was performed by the derivatization method for which 9-Fluorenylmethyl chloroformate was used as the derivatization agent. In this method, the ideal conditions for the substance to interact with the FMOC reagent were pH 9 buffer medium with acetonitrile/water phase ratio of 4, heating at 60 degrees C for 5 minutes. Gabapentin was used as the internal standard. Pregabalin-FMOC derivative was measured and analyzed in the C18 column by 20.0 mM potassium phosphate buffer-acetonitrile (70:30, v/v) mobile phase system with a flow rate of 1.0 mL/min, while the derivatives were measured using a fluorescence detector with excitation at 260 nm and emission at 315 nm wavelengths. The calibration curve showed linearity in the 0.5-6.0 mu g/mL range, whereas the limits of detection and quantification were found to be 0.039 mu g/mL and 0.117 mu g/mL, respectively. The average recovery calculated by the standard addition method is 101.39%. The results obtained from the method successfully applied to the analysis of pregabalin in tablets were compared with those obtained by the pharmacopoeia method by applying the Student-t and Fisher-F tests.