Abstract
A new simple and precise stability indicating bioanalytical reverse-phase High Performance Liquid Chromatography (RP-HPLC) method was developedand validated for the simultaneous estimation of Eprosartan and Hydrochlorothiazidein their formulation and in human plasma.The developed method was successfully used for assaying drug contents in plasma. Isocratic elution mode was carried at Symmetry C 18 (150mm x 4.6 mm, 5) column using 0.1% Orthophosphoric acidpH (2.2): Acetonitrile (65:35v/v) as mobile phase at flow rate 1.0mlmin at detection wavelength 240 nm. Valsartan was taken as an internal standandard. The method was validated as per ICH guidelines. It is concluded that the present validated method can be successfully applied for the estimation of Eprosartan and Hydrochlorothiazidein human plasma over the concentration range of 80 to 3200 ng /ml of Eprosartan, 8.5 to 340 ng /ml of Hydrochlorothiazide. The method for determination of Eprosartan and Hydrochlorothiazidein human plasma using HPLC detection met the acceptance criteria with respect to selectivity, precision, accuracy, linearity, recovery. Key words: ICH guidelines, Eprosartan, Hydrochlorothiazide, K2EDTA Plasma,Valsartan, Internal standard, Validation
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