New analytical method development and validation for estimation of eprosartan and hydrochlorothiazide in bulk and tablet dosage form by rp-hplc method

Abstract

A new RP-HPLC method has been developed and validated for the simultaneous quantification of Eprosartan and Hydrochlorothiazide in both bulk and pharmaceutical formulations. The separation was achieved using a Phenomenex Luna C18 column (4.6×250mm, 5µm) with an isocratic mobile phase of Acetonitrile: Phosphate Buffer (pH 4.6) (45:55 v/v) at a flow rate of 1.0 mL/min. Detection was performed at 245 nm, with retention times of 2.102 and 3.537 minutes for Eprosartan and Hydrochlorothiazide, respectively. The method exhibited linear response over the concentration ranges of 6µg/mL to 14µg/mL for Eprosartan and 18µg/mL to 42µg/mL for Hydrochlorothiazide, with correlation coefficients of 0.999 for both analytes. The limits of detection (LOD) and quantification (LOQ) were determined to be 0.6 µg/mL and 1.8 µg/mL for Eprosartan, and 0.8 µg/mL and 2.4 µg/mL for Hydrochlorothiazide, respectively. Method validation according to ICH guidelines confirmed the method's accuracy, precision, specificity, and robustness. The percentage recoveries for Eprosartan and Hydrochlorothiazide were 100.351% and 100.93%, respectively, indicating high accuracy. Specificity testing demonstrated good correlation between retention times of standards and samples, ensuring the method's ability to differentiate and quantify analytes in the presence of tablet excipients. In conclusion, the developed RP-HPLC method offers a simple, precise, accurate, and reproducible approach for the simultaneous determination of Eprosartan and Hydrochlorothiazide in pharmaceutical formulations, making it suitable for routine quality control analysis.