Spectrophotometric determination of alendronate in pharmaceutical formulations via complex formation with Fe(III) ions

The formation of the complex between alendronate, non-chromophoric bisphosphonate drug important for the treatment of a variety of bone diseases, and iron(III) chloride in perchloric acid solution was studied. The stoichiometric ratio of alendronate to Fe(III) ions in the chromophoric complex was determined to be 1:1. The conditional stability constant was log K'(ave) = 4.50 (SD = 0.15), indicating that the Fe(III)-alendronate complex is a complex of medium stability. The optimum conditions for this reaction were ascertained and a spectrophotometric method was developed for the determination of alendronate in the concentration range 8.1-162.5 mug ml(-1), the detection limit being 2 mug ml(-1). The method was validated for the direct determination of alendronate in tablet dosage formulations. (C) 2002 Elsevier Science B.V. All rights reserved.