RP-HPLC VALIDATION OF RELATED SUBSTANCES OF NEBIVOLOL IN BULK & 2.5/5/10/20 MG TABLETS
Journal Title: International Journal of Pharmaceutical, Biological and Chemical Sciences (IJPBCS) - Year 2012, Vol 1, Issue 2
Abstract
A gradient reverse phase HPLC method was developed for the determination of related substances in Nebivolol in bulk and their tablets. The known related substances are Desfuoroimpurity[1-(chroman-2-yl)-2-(2-(6fluorochroman-2-yl)-2-hydroxyethylamino)ethanol hydrochloride],Related compound-A [2S*{1R*,5R*(S*)}]-α,α`-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanolhydrochloride] and benzylated impurity[2,2`-(Benzylazanediyl)bis(1-(6-fluorochroman-2yl)ethanol)oxalate]. The method was carried out on a Kinetex C18 column (75 x 4.6 mm; 2.6µ) using a mobile phase mixture of buffer pH 3.4, acetonitrile and water in a gradient elution at a flow rate of 1.0ml/min at wavelength of 280 nm. The impurities separated with a RRT of 0.9 for desfluoro, 1.06 for related impurity-A and 1.27 for benzylated impurity with respect to Nebivolol. The method can be used for the detection and quantitative estimation of known and unknown impurities in drug and pharmaceutical dosage form.
Authors and Affiliations
EDIGA SASI KIRAN GOUD*1 , V. KRISHNA REDDY2
IMPROVE ORAL BIOAVAILABILITY OF ACECLOFENAC USING SOLID DISPERSIONS BY DROPPING METHOD
The objective of the present investigation was to study the effect of polyethylene glycol 8000 (PEG 8000) on in vitro dissolution of Aceclofenac from solid dispersions. Initial studies were carried out using physical mix...
QUALITY EVALUATION OF MARKETED FORMULATION OF MOUTH DISSOLVING VOGLIBOSE TABLETS
The main objective of this study was to compare the five brands of mouth dissolving tablets containing voglibose, an antidiabetic. Novel MDT technique provides the patient compliance and also meets the pharmaceutical...
A REVIEW OF NOVEL APPROACH IN BILAYER TABLET TECHNOLOGY
Over the past 30 years as the expense and complications involved in marketing new drug entities have increased, with concomitant recognition of the therapeutic advantages of controlled drug delivery, greater attention ha...
DEVELOPMENT AND VALIDATION OF ANALYTICAL TECHNIQUE FOR NON STEROIDAL ANTI INFLAMMATORY DRUGS (NSAIDs) BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)
Drug analysis plays an important role in the development of drugs, their manufacture and therapeutic use. Pharmaceutical industries rely upon quantitative chemical analysis to ensure that the raw material used and final...
ESTIMATION OF RELATED SUBSTANCES OF FEBUXOSTAT IN BULK & 40/80/120mg TABLETS BY RP-HPLC
A simple reverse phase liquid chromatographic method was developed for the determination of related substances in Febuxostat in bulk and Tablets. The related substances amide impurity, methyl ester impurity and ethyl est...