A simple reversed phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of Zonisamide and Lamotrigine in combined dosage form and human plasma. The separation was achieved using a Phenomenex 250 mm × 4.6 mm i.d., 5 μm particle size C18 column. Mobile phase containing a mixture of Methanol and phosphate buffer (pH 6.5) (60: 40 v/v) was pumped at a flow rate of 1.0 mL/min. UV detection was performed at 295 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The developed and validated method was successfully used for quantitative analysis of combined dosage form. The chromatographic analysis time was approximately 10 min per sample with complete resolution of Zonisamide (tR = 4.64 min.) and Lamotrigine (tR = 6.88 min). Validation studies were performed according to ICH Guidelines revealed that the proposed method is specific, rapid, reliable and reproducible. The calibration plots were linear over the concentration ranges 0.1 - 2.0 μg/mL and 0.6 - 2.4 μg/mL with LOD of 0.01 μg/mL and 0.05 μg/ml for both compounds and limits of quantification 0.1 μg/mL and 0.2 μg/mL for Zonisamide and Lamotrigine respectively. The developed method was successfully applied for the simultaneous analysis of the studied drugs in their combined form and human plasma. The mean percentage recoveries in were 99.547 ± 1.687 and 99.563 ± 1.674 for Zonisamide and Lamotrigine respectively. The method was found to be robust proved that there was no significant difference in the accuracy and precision.
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