UV spectroscopy for assay development and pharmaceutical drug formulation

UV absorbance has been successfully used as a simple and low-cost method for bioanalysis and quality control in bulk drug and pharmaceutical formulation. As an example, the method  was  effectively used  to  analyze  febuxostat  in drug formulations  without   interference  from excipients.  The UV absorbance method was validated and shown to be fast, accurate, precise and  robust and  can  be  used  for  routine  quality  control  of various drug dosage formulations.[xii][xiii]

UV/Vis spectroscopy can also be used as a rapid method for determining protein concentrations and the number of drugs conjugated to antibody in an antibody-drug conjugate (ADC). Using the extinction coefficients of the antibody and the drug ADC absorbance data, it is possible to determine the average drug-to-antibody ratio (DAR).[xiv]

[xii] A. Bhagwat et al, “Development and Validation of UV Spectroscopic Assay Method of Febuxostat in Bulk and Dosage Form”,  World Journal of Pharmaceutical Research, April 2017.

[xiii] M. Maleque, “Development and validation of a simple UV spectrophotometric method for the determination of levofloxacin both in bulk and marketed dosage formulations”, Journal of Pharmaceutical Analysis, Volume 2, Issue 6, December 2012, Pages 454-457

[xiv] Chen Y, “Drug-to-antibody ratio (DAR) by UV/Vis spectroscopy”, Methods Mol Biol. 2013;1045:267-73.