Simultaneous Estimation of Nebivolol Hydrochloride and Hydrochlorothiazide in Tablets by TLC-Densitometry

摘要

A simple, rapid and accurate thin-layer chromatography (TLC)–densitometric method has been established and validated for the simultaneous determination of nebivolol hydrochloride and hydrochlorothiazide in tablets. The method is based on TLC separation of the two drugs followed by densitometric measurements of their spots at 281 nm. The separation was carried out on Merck TLC aluminium plate of silica gel 60F 254 using toluene:ethyl acetate:methanol:ammonia (3:2.7:1.7:0.1 v/v/v) as a mobile phase. Nebivolol hydrochloride and hydrochlorothiazide gave sharp and well defined peak at Rf 0.68 and 0.38, respectively. Calibration curves for nebivolol hydrochloride and hydrochlorothiazide were linear in range 500-3000 ng/spot and 1000-6000 ng/spot, respectively. Method was successively applied to tablet formulation. No chromatographic interferences from the tablet excipients were found. The method was validated in accordance with the requirements of ICH guidelines.