Leflunomid In Farmasötik Preparatlardan Analizi Için Kapiler Elektroforez Yöntemi Geliştirilmesi ve Validasyonu

Abstract

In this study, a new micellar electrokinetic capillary chromatography (MEKC) method was developed to analysis of Leflunomide in pharmaceutical preparations. Best results in the MEKC method were obtained by the use of pH 9.5 25 mM borate buffer containing 70 mM sodiumdodecylsulphate as the background electrolyte. Analysis were performed using a fused silica capillary (50 μm internal diameter, 48.5 cm total length, 40.0 cm effective length) at 20°C with the application of 5 seconds of hydrodynamic injection at 50 mbar pressure and a potential of 25 kV. Caffeine was used as internal standard. Detection was performed with a diode array detector at 260 nm. In specified conditions, the migration time for Leflunomide and Caffeine were 3.20 and 6.81 min, respectively. Developed MEKC method were accurate, precise, specific, sensitive, rugged and robust according to the validation study results. Also the linearity range was 5-150 μg/mL and the detection limit was found to be 2 μg/mL in method. The pharmaceutical preparations which containing Leflunomid were analyzed by the developed and validated MEKC method. Same preparations were also analyzed by a chromatographic method reported in the pharmacope, the results were compared statistically and no significant differences were found between the analysis results.