New Validated RP-HPLC Method for Simultaneous Estimation of Valsartan and Nebivolol in Bulk and Dosage Forms

Abstract

The main reason of this work to develop a sensitive, rapid, economic, precise reverse phase liquid chromatographic method to separate and assay the simultaneous determination of Valsartan and Nebivolol as a minor component in bulk and dosage forms. The separation was carried out using SHIMADZU UV-photo diode array detector at 200, 245 nm for Nebivolol and Valsartan respectively equipped with reverse phase C18 column Sunniest 5μm, 4.6 mm, 250 mm at 40˚C oven temperature, flow rate of 1 mL/min with mobile phase consist of 70:30 methanol: 10 mM phosphate buffer pH=3. The retention time of Nebivolol and Valsartan were to be found at 4.3 min and 8 min respectively. The method was validated according to ICH guidelines. The linearity of the proposed method was investigated in concentration range of 45.8-229% r=0.9997 for Nebivolol and the range 55-166%, r=0.9999 for Valsartan. Robustness in the case of little change of some chromatographic conditions. Validation of the proposed method was carried out for its linearity, accuracy, precision, robustness and assay. This method can be applied easily in routine work analysis to detrmine the estimation of nebivolol and valsartan in bulk and dosage forms.