Abstrato

Development and validation of a stability indicatimg HPLC method for the simultaneous determination of captopril and indapamide

Bahia Abbas Moussa, Ashraf Hassan Abadi, Hanan Abou Youssef, Marianne Alphonse Mahrouse

A simple, selective, precise and stability indicating reversed phase HPLC method was developed and validated for the simultaneous determination of captopril (CAP) and indapamide (IN) in presence of their degradation products, using hydrochlorothiazide (HZ) as internal standard, in powder and tablets. The separationwas achieved on anAgilent Zorbax C18 column,with isocratic flow. The mobile phase consisted of methanol:water:triethylamine (42.5:57.5:0.028, v/v/v), adjusted with o-phosphoric acid to pH 2.5. The flowrate wasmaintained at 2mlmin-1. The UV detection was carried out at 220 nm for CAP, CAP oxidation product and IN degradation product (I) and 242 nm for IN and 272 nm for HZ. Linearity was demonstrated with good correlation coefficients (0.9998), over the concentration range of 27.5–550 ìg.ml-1and 2.5– 50 ìg.ml-1, in case of CAP and IN, respectively. The method was successfully validated in accordance to ICH guidelines. Individual drugs (CAP and IN) were exposed to hydrolytic and oxidative stress conditions. The method gave high resolution among the degradation products and the analytes. The proposed method is accurate, stability indicating and successfully applied for the determination of CAP and IN in synthetic mixtures and tablets.