Abstract

Stability study of the angiotensin converting enzyme inhibitor moexipril and its simultaneous determination with hydrochlorothiazide and moexiprilat by reversed phase chromatography in pharmaceutical formulation and plasma

Author(s): A.Hemdan M.Farouk, Omar Abd Elaziz, Shereen M.Tawakkol, Mostafa A.Shehata

A sensitive, reproducible, and rapid stability indicating RP-HPLC method was developed and subsequently validated for simultaneous determination ofmoexipril (MOX), its activemetabolitemoexiprilat (MOXT), and hydrochlorothiazide (HCTZ) in bulk powder, pharmaceutical formulation, and human plasma, using benazepril (BENZ) as an internal standard (IS). The method uses Inertsil C18 column (250 x 4.6mm, 5µ) and acetonitrile-potassium hydrogen phosphate buffer pH = 6.2 (40/60 v/v) as a mobile phase. The flow rate was 1.0 mL/min and the detection wavelength was 282 nm.A detailed validation of the method was performed following the ICH guidelines and the standard curves were found to be linear in the range of 5-100, 5-100, and 1–100 µg/mL for MOX, MOXT, and HCTZ, respectively. Statistical comparison was done between the proposed method and the reported one where no significant difference was found between the two methods.