SIMULTANEOUS QUANTITATIVE DETERMINATION OF HYDROCHLOROTHIAZIDE AND IRBESARTAN BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Abstract

In this study, an HPLC method for the simultaneous analysis of hydrochlorothiazide and irbesartan in pharmaceutical formulations was developed and validated. The chromatographic separation was performed on a Nucleosil 100 column (250 x 4.6 mm; 5 μm). The mobile phase consisted of two solvents: Mobile Phase A (0.1% trifluoroacetic acid in water) and Mobile Phase B (0.1% trifluoroacetic acid in acetonitrile). A gradient elution program was employed with a flow rate maintained at 1.5 mL/min, and the injection volume was set to 20 μL. Detection was carried out at a wavelength of 205 nm. The results demonstrated good linearity (R² > 0.999) with linear regression equations of y = 49739x for HCTZ and y = 118902x for IRB. The accuracy and precision of the method met the required criteria, with an RSD of less than 2%. The average recovery rate ranged from 100.29% to 101.95% for HCTZ and from 99.14% to 100.18% for IRB. The validation data showed that the method was validated according to the guidelines and met the ASEAN requirements for analytical method validation.