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 (250x4.0 mm id, 5 microm) 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 microg/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.
Carlucci
Giuseppe
G
Dipartimento di Scienze del Farmaco, Università degli Studi G. D'Annunzio Chieti-Pescara, Chieti, Italy. g.carlucci@unich.it
Di Federico
Lucia
L
Iuliani
Piera
P
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000032:analysis*; D002138:Calibration; D002216:Captopril / Q000031:analogs & derivatives* / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004232:Diuretics / Q000032:analysis*; D006852:Hydrochlorothiazide / Q000032:analysis*; D057230:Limit of Detection; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012015:Reference Standards; D015203:Reproducibility of Results
D000806:Angiotensin-Converting Enzyme Inhibitors; D004232:Diuretics; D004364:Pharmaceutical Preparations; D006852:Hydrochlorothiazide; C044958:zofenopril; D002216:Captopril