Determination of nebivolol and valsartan in a fixed-dose combination by liquid chromatography

Abstract

An accurate and reproducible liquid chromatographic assay method was developed and validated for the determination of nebivolol and valsartan in a capsule formulation. Buffer-acetonitrile (55 + 45, v/v) was used for reversed-phase liquid chromatography to determine the contents of nebivolol and valsartan in the combination-capsule dosage form. The method was validated by determining parameters such as specificity, linearity, limits of detection and quantitation, precision, accuracy, and robustness. The method was found to be specific against placebo interference. Linearity was evaluated over the concentration ranges of 2-8 micro/mL for nebivolol and 32-128 microg/mL for valsartan (the correlation coefficient was 0.9999 for both nebivolol and valsartan). Both the intraday and interday precision values of the system and the method were determined. The accuracy of the method ranged from 100.66 to 102.58% for nebivolol and from 101.17 to 101.85% for valsartan. The proposed method was found to be robust when slight but deliberate changes were made in the analytical conditions. The developed method was found suitable for the assay determination of nebivolol and valsartan in a capsule formulation.