Development and Validation of a Forced Degradation UPLC Method for the Simultaneous Determination of Nebivolol HCl and Valsartan in Bulk and Pharmaceutical Dosage Form

Abstract

An excellent method with simple, precise was developed for Nebivolol HCl and Valsartan by using Forced degradation UPLC method. The column used was C-18 BEH _ 1.7µm x 2.1 x 50mm in ambient temperature. Flow rate was 0.8ml/min, wavelength of 278nm, mobile phase used was acetonitrile : Buffer (50:50). Buffer used 0.01 N Disodium hydrogen phosphate with pH 3.5 adjusted by OPA. Run time 4 min. The percentage purity and RT of Nebivolol HCl and Valsartan was found to be 99.72 and 99.30 and 1.193 and 1.827 respectively. The validation parameters was carried out, linearity of Nebivolol HCl was found to be (1μgm/ml to 8μgm/ml) R2= 0.998 and Valsartan was found to be (16μgm/ml to 128.8μgm/ml) R2= 0.999. Intermediate precision, Robustness, LOD LOQ was within the limit as per ICH guidelines. Recovery studies taken place in 80%, 100% and 120. Forced Degradation was carried out in three conditions acidic, basic and peroxide condition, degradation takes at basic and peroxide. As per literature review there is no method developed for Nebivolol HCl and Valsartan in Forced degradation UPLC method. So we made attempt to develop the Nebivolol HCl and Valsartan in UPLC method.