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    STUDIA CHEMIA - Issue no. 4 / 2014  
         
  Article:   VALIDATED HPLC METHOD FOR DETERMINATION OF NEBIVOLOL IN PHARMACEUTICAL DOSAGE FORM AND IN VITRO DISSOLUTION STUDIES.

Authors:  . 		 
       
         
  Abstract:  A rapid and simple liquid chromatographic method was developed and validated according to current ICH guidelines for the quantitative assessment of nebivolol from tablet dosage forms and dissolution medium. Chromatography was carried out on a BDS Hypersil C18 column (150 x 4.0 mm, particle size 5 μm), employing a Merck 7000 series HPLC system with UV detection at 281 nm. The mobile phase consisted of 0.1 % (v/v) trifluoroacetic acid in water: acetonitrile (60:40, v/v) and was delivered at a flow rate of 1.25 mL min-1. Injection volume was 100 μL and the analysis was performed at ambient temperature. The developed method was validated taking into consideration current international guidelines for specificity, linearity, accuracy, precision (system precision and both intra- and interday precision). The validated analytical method proved to be suitable for quantitative analysis of nebivolol from commercially available tablets and also performed well in determination of active substance during dissolution studies. 

 Keywords: nebivolol, dissolution, HPLC
 
         
     
         
         
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