HPLC-DAD method for the simultaneous determination of zofenopril and hydrochlorothiazide in oral pharmaceutical formulations

An HPLC method with DAD detection was developed and validated for the simultaneous determination of zofenopril and hydrochlorothiazide in tablets. The separation was carried out through a gradient elution using an Agilent LiChrospher C18 column (250 x 4.0 mm id, 51 mu m) and a mobile phase consisting of (A) water TFA (99.9:0.1 v/v) and (B) acetonitrile TFA (99.1:0.1 v/v) delivered at a flow-rate of 1.0 mL/min. 8-Chlorotheophylline was used as internal standard. Calibration curves were found to be linear for the two drugs over the concentration ranges of 5.0-40 and 1.0-20 mu g/mL for zofenopril and hydrochlorothiazide, respectively. Linearity, precision, accuracy, specificity and robustness were determined in order to validate the proposed method, which was further applied to the analysis of commercial tablets. The proposed method is simple and rapid, and gives accurate and precise results.