A Sensitive Validated Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Losartan Ramipril and Hydrochlorthiazide in Bulk and Tablet Dosage Form with Forced Degradation Studies

摘要

An accurate reproducible and efficient isocratic reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous estimation of Losartan, Ramipril and Hydrochlorothiazide. All the drugs were separated on an Altima 150 mm x 4.6 mm, 5? Column. The mobile phase, optimized through an experimental design, was a 65:35 (v/v) mixture of buffer and acetonitrile, pumped at a flow rate of 1 ml/min. UV detection was performed at 210 nm. The retention time of Losartan, Ramipril and Hydrochlorothiazide was found to be 7.33, 6.04 and 2.53 min respectively. The method was validated in the sample concentration ranges of 40-240μg/ml for losartan, 1-6 μg/ml for Ramipril and 10-60μg/ml for hydrochlorothiazide. The method demonstrated to be robust, resisting to small deliberate changes in pH and flow rate of the mobile phase. The LOD values were 0.10μg/ml, 0.07 μg/ml and 0.13 μg/ml, while the LOQ values were 0.31μg/ml,0.20 μg/ml and 0.39μg/ml for Losartan, Ramipril and Hydrochlorothiazide.