Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry


Development and Validation of Novel RP-HPLC Method for Simultaneous Determination of Ramipril, Hydrochlorothiazide and bisoprolol in Ternary Combinations

Author(s): Shoeb Alahmad, Hamed M Elfatatry, Mokhtar M Mabrouk, Sherin F Hammad, Fotouh R Mansour

The present work describes a novel reversed phase high performance liquid chromatographic method for the determination of Bisoprolol Fumarate (BIS), Hydrochlorothiazide (HCT) and Ramipril (RAM) in their synthetic mixtures and dosage forms. The developed method performed on a Hypersil® C18 reversed phase column (250 mm × 4.6 mm, particle size 5 μm) using a mobile phase consisting of acetonitrile: methanol: buffer (0.01 M potassium dihydrogen ortho phosphate; pH 3.5) in a ratio of 65:15:20 (v/v/v). The flow rate was 1 ml/min and detection was carried out at 210 nm. The retention times of BIS, HCT and RAM were 2.2, 2.6 and 4 min, respectively. The method showed linearity over the concentration range of 5-40 μg/ml for each drug. The described High performance Liquid Chromatography (HPLC) method was successfully applied for simultaneous determination of those drugs in their combined dosage form. The mean percentage recoveries were found to be 99.37%, 98.75% and 99.48% for BIS, HCT and RAM, respectively. Validation of the method was carried out according to the guidelines of the International Conference on Harmonization (ICH).