Analytical Method Development and Validation for Simultaneous Estimation of Nebivolol and Valsartan in Tablet Dosage Form by RP-HPLC

Abstract

A rapid, sensitive, simple and precise reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of nebivolol and valsartan in tablet dosage forms has been developed. The compounds were well separated on Waters HPLC 2965 system using Alltima C₁₈ column (150 mmX4.6 mm, dp=5 mm) and PDA detector with mobile phase consisting of buffer containing 3.3pH Potassium di hydrogen phosphate: acetonitrile: methanol in the ratio 45:35:20 at a flow rate of 1.0 mL/min with injection volume at 20ml and wavelength monitered at 280 nm, The Rt for Nebivolol & Valsartan were found to be 2.463& 4.017mins, respectively. Validation of the proposed method was carried out according to International Conference on Harmonisation (ICH) guidelines. Linearity range was obtained for NB and VT over the concentration range of 2.5-15 and 40-240mg/mL and the r² values were 0.999 for both drugs. The calculated %RSD and recoveries of the Nebivolol and Valsartan were 0.62, 0.63 and 100.54%, 101.02% correspondingly. The calculated LOD and LOQ values were 0.09ppm, 0.31ppm and 0.28ppm, 0.95ppm correspondingly. Thus the present study showed that the developed RP-HPLC method is sensitive and selective for estimation of Nebivolol and Valsartan in combined dosage form.

Keywords: Nebivolol, Valsartan, RP-HPLC, ICH guidelines.