A High-Performance Liquid Chromatography Method Development for Leflunomide Analysis and Validation

In this study, we developed and validated a rapid and precise RP-HPLC method to quantify leflunomide in bulk and tablet dosage forms. The analysis was performed using an Inertsil-ODS C18 column (250x4.6mm, 5μm) with a mobile phase composed of 95:5 methanol/water at a flow rate of 1mL/min. Leflunomide demonstrated a linear range between 20-70μg/ml with a high correlation coefficient (R² = 0.995). Adhering to ICH guidelines, the method was designed to be accurate, precise, sensitive, selective, repeatable, and robust. The validation parameters included system suitability, specificity, linearity, accuracy, precision, detection limit, quantitation limit, robustness, and stability. The results indicated excellent accuracy and precision, with recoveries close to 100% and relative standard deviations well within acceptable limits. The method's sensitivity allowed for reliable detection and quantification at low concentrations, making it ideal for routine quality control. Additionally, robustness studies confirmed the method's reliability despite minor changes in experimental conditions. This HPLC method is both efficient and cost-effective, enabling faster analysis while maintaining high quality. The validated method was successfully applied to the analysis of leflunomide in pharmaceutical formulations, proving its suitability for routine use in quality control laboratories. Overall, this method offers a comprehensive solution for accurately estimating leflunomide in various dosage forms.