Abstract
Hydrochlorothiazide (HCZ) and Amiloride hydrochloride (AMH) are generally co-formulated in antihypertensive formulations. Different analytical methods have been developed for their simultaneous determination in their binary mixtures but none of them analyzed both drugs in the presence of related impurities of HCZ; Salamide (DSA) and Chlorothiazide (CTZ). Accordingly; a simple, sensitive and highly selective RP-HPLC method was developed for their simultaneous determination in pure form and pharmaceutical formulations. Chromatographic separation was carried out within 10 min using an ODS-C18 column (250×4.6 mm, 5 µm) using 0.05 MKH2PO4 : acetonitrile: triethylamine (90: 10: 0.3 by volume, pH 3.6) as mobile phase, flow rate 1.5 mL min−1 with UV detection at 260 nm.Calibration curves were builtin the range of 1-50, 1-20, 1-12 and 1-20 µg mL-1 for HCZ, AMH, DSA and CTZ, respectively. HCZ and AMH were successfully analyzed in their pure and pharmaceutical form. The results obtained were statistically compared to those obtained by the reported method with no significant difference, therefore the proposed method can be applied in routine quality control analysis of the drug products.
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