Akademik Veri Yönetim Sistemi
ACTA CHROMATOGRAPHICA, 2025 (SCI-Expanded)
In this study, a simple, rapid, and sensitive capillary electrophoresis (CE) method was developed that allows simultaneous analysis of zonisamide (ZNS), rufinamide (RFN), and lamotrigine (LMT) in pharmaceutical preparations. This study introduces the first application of CE for the simultaneous determination of ZNS, RFN, and LMT in pharmaceutical dosage forms. For the comparison a High-Performance Liquid Chromatography (HPLC) method was developed. In CE method, detection was achieved using a photodiode array detector (DAD) at a wavelength of 210 nm. A capillary with an internal diameter of 75 mu m and an effective length of 40 cm was used for separation. The optimum conditions were achieved using 35 mM SDS, 6 mM borate, 10 mM phosphate buffer (pH 9.00) containing 5% isopropyl alcohol (IPA), and applying a potential of 15 kV. Under these conditions, the migration times of ZNS, RFN and LMT were observed to be 5.99 min, 6.77 min and 8.46 min, respectively. In HPLC method, detection was achieved using a photodiode array detector at a wavelength of 210 nm. A C18 column (4.6 x 100.0 mm, 3.5 mu m i.d.) was used for separation, with a mobile phase consisting of acetonitrile and pH 4.0 50 mM phosphate buffer (18:82, v/v) at a flow rate of 1.0 mL min-1. In this method, the retention times of ZNS, RFN and LMT were observed to be 6.41 min, 7.29 min and 4.95 min, respectively. The validity of the developed methods was examined through parameters such as linearity, precision, accuracy, sensitivity, stability, and robustness. In CE method, the limit of detection (LOD) values for ZNS, RFN and LMT were calculated as 0.035 mu g mL-1, 0.016 mu g mL-1 and 0.007 mu g mL-1, respectively. For HPLC method, the LOD values were determined as 0.003 mu g mL-1, 0.002 mu g mL-1 for RFN and 0.001 mu g mL-1 for LMT. Both developed methods were successfully applied to pharmaceutical dosage forms and shown to be compliant with United States Pharmacopeia (USP 47 - NF 42). In conclusion, both methods developed in our study yielded comparable results in terms of robustness and analysis time. HPLC demonstrated higher sensitivity compared to CE and is preferred for analyses at very low concentrations, while CE is ideal for green chemistry applications due to its minimal solvent and sample consumption.