A stability-indicating LC method for the simultaneous determination of ramipril and hydrochlorothiazide in dosage forms

Abstract

A simple, rapid and sensitive HPLC method has been developed for the simultaneous determination of ramipril and hydrochlorothiazide in their dosage forms. Acetonitrile: sodium perchlorate solution (0.1 M) adjusted to pH 2.5±0.2 with phosphoric acid (46:54 v/v), was used as the mobile phase, at a flow rate of 1.5 ml/min. A supelcosil™ LC-8 column (5 μm), 15 cm×4.6 mm i.d. was utilized as stationary phase. Detection was affected spectrophotometrically at 210 nm. Clobazam was used as an internal standard. The method was also applied for the determination of ramipril in the presence of its degradation products. Linearity ranges for ramipril and hydrochlorothiazide were 4.5–45 and 0.6–14 μg/ml, respectively. Minimum detection limits (S/N=2) obtained were 180 and 23 ng/ml for ramipril and hydrochlorothiazide, respectively. The proposed method was further applied to the analysis of tablets containing the two drugs, the percentage recoveries±S.D. (n=5) were 100.45%±0.63 and 99.55%±0.78 for ramipril and hydrochlorothiazide, respectively.