Analytical Method Development and Validation for Estimation of Fimasartan in Bulk Drug and Pharmaceutical Dosage Form

A research presents the development and validation of a reliable and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative estimation of Fimasartan in pharmaceutical tablet formulations. Fimasartan, a selective non-peptide angiotensin II type 1 (AT1) receptor blocker, is widely prescribed for managing essential hypertension. Regulatory standards. The method employed a Phenomenex C18 column under isocratic conditions, using a mobile phase consisting of acetonitrile and 0.05% orthophosphoric acid in water in a 75:25 (v/v) ratio. Chromatographic separation was achieved at a flow rate of 1.0 mL/min, with UV detection at 262 nm. The method exhibited excellent linearity within the concentration range of 10.0–30.0 µg/mL, with a correlation coefficient (R²) of 0.99998. The limits of detection (LOD) and quantification (LOQ) were found to be 0.156 µg/mL and 0.472 µg/mL, respectively. Validation, carried out according to ICH Q2(R1) guidelines, confirmed the method’s accuracy, with recovery results ranging from 98.90% to 100.89%. The method also demonstrated high precision (%RSD < 1.5), specificity, and robustness when subjected to deliberate variations in chromatographic parameters. Stability studies confirmed that sample solutions remained stable for at least 24 hours, while filtration tests indicated no significant analyte loss when using PVDF or nylon syringe filters. The validated method was successfully applied for the assay of commercially marketed Fimasartan tablets (Fimagen 60 mg), delivering consistent and reproducible outcomes. Overall, the proposed RP-HPLC method is simple, rapid, and highly suitable for routine quality control and analysis of Fimasartan in both bulk and finished dosage forms.