Abstract
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.
Highlights
Nebivolol hydrochloride (NEB), α, α’ [iminobis] bis [6-fluro-3, 4- dihydro-2H -1-benzopyran-2-methanol] hydrochloride is an antihypertensive [1,2].Nebivolol hydrochloride occurs in two isomeric forms [3]. (+) Nebivolol acts as strong adrenergic β1 blocker whereas (-) nebivolol as vasodilator [4,5]
RP-HPLC method has been found for simultaneous determination of NEB and HCTZ in combined dosage form [22]
The present paper describes a reliable, rapid and accurate method for determination of NEB and HCTZ using thin-layer chromatography (TLC)-densitometry
Summary
Nebivolol hydrochloride (NEB), α, α’ [iminobis (methylene)] bis [6-fluro-3, 4- dihydro-2H -1-benzopyran-2-methanol] hydrochloride is an antihypertensive [1,2].Nebivolol hydrochloride occurs in two isomeric forms [3]. (+) Nebivolol acts as strong adrenergic β1 blocker whereas (-) nebivolol as vasodilator [4,5]. Hydrochlorothiazide (HCTZ), 6- chloro-3, 4-dihydo-2H-1, 2, 4-benzothizdiazine-7-sulfonamide dioxide is a popular thiazide diuretics acts on the kidneys to reduce sodium (Na) reabsorption in the distal convoluted tubule [6]. Both these drugs are used in the treatment of arterial hypertension. RP-HPLC method has been found for simultaneous determination of NEB and HCTZ in combined dosage form [22]. Different volumes in the range 1–6 μL of NEB and HCTZ solutions were over spotted on TLC plates with the help of microlitre syringe, using Linomat V sample applicator. Peak area was recorded for each concentration of drugs and curves (concentration vs. peak area) were constructed
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
