DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF SINGLE DRUG IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

The present study focuses on the development and validation of a simple, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of Eslicarbazepine Acetate (ESC) in pharmaceutical tablet formulations. ESC, a widely prescribed antiepileptic agent, requires precise quantification to ensure quality control and regulatory compliance. The chromatographic method was optimized using an Inertsil C18 column (4.6 mm × 250 mm, 5 µm) with a mobile phase composed of Acetonitrile and Ammonium Phosphate Buffer (70:30 v/v, pH 3), and detection was performed at 228 nm using a UV detector. The method produced a sharp and well-resolved peak with a retention time of 5.684 minutes and an asymmetry factor of 1.1754, demonstrating excellent efficiency and system suitability. The linearity of the method was confirmed over a concentration range of 80%–120% with a correlation coefficient (R²) of 0.9999. Validation was conducted in accordance with ICH guidelines, assessing parameters such as accuracy, precision, specificity, ruggedness, robustness, and linearity. The method demonstrated high recovery (100.21%) and minimal variability (RSD < 2%), indicating its reliability and reproducibility. The developed RP-HPLC method was successfully applied for the quantitative estimation of ESC in both laboratory mixtures and marketed formulations, showing its potential for routine quality control analysis. KEYWORDS: Eslicarbazepine Acetate (ESC); RP-HPLC; Method Validation; Pharmaceutical Formulation; Chromatography; Accuracy; Precision; ICH Guidelines