title: Micelle-enhanced spectrofluorimetric determination of amlexanox in bioadhesive buccal tablets: application to content uniformity testing.
abstract: A highly sensitive, simple and rapid spectrofluorimetric method was developed for the determination of Amlexanox (AMX) in its bioadhesive buccal tablets. The proposed method is based on measuring the native fluorescence of the methanolic solution of AMX at 400 nm after excitation at 242 nm in 0.2 M borate buffer (pH 10) and 0.5% w/v sodium dodecyl sulfate (SDS) solution. The interaction of AMX with SDS was studied, and the enhanced fluorescence intensity was exploited to develop an assay method for the determination of AMX. The relative fluorescence intensity-concentration plot was rectilinear over the range 5.0-80.0 ng/mL, with a lower detection limit of 0.57 ng/mL and a lower quantification limit of 1.74 ng/mL. The proposed method was successfully applied to the analysis of AMX in its commercial tablets. Moreover, content uniformity testing was conducted by applying official USP guidelines. Statistical evaluation and comparison of the data obtained using the proposed and comparison methods revealed good accuracy and precision for the proposed method.
authors.affiliation: Department of Analytical Chemistry, University of Mansoura, Mansoura, Egypt.
authors.forename: M I
authors.initials: MI
authors.lastname: Walash
authors.affiliation: Department of Analytical Chemistry, University of Mansoura, Mansoura, Egypt.
authors.forename: F
authors.initials: F
authors.lastname: Belal
authors.affiliation: Department of Analytical Chemistry, University of Mansoura, Mansoura, Egypt.
authors.forename: M M
authors.initials: MM
authors.lastname: Tolba
authors.affiliation: Department of Analytical Chemistry, University of Mansoura, Mansoura, Egypt.
authors.forename: M I
authors.initials: MI
authors.lastname: Halawa
mesh_terms: D000278:Administration, Buccal; D000631:Aminopyridines / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D057230:Limit of Detection; D008823:Micelles; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry; D012997:Solvents; D013050:Spectrometry, Fluorescence / Q000379:methods*; D013607:Tablets / Q000032:analysis* / Q000737:chemistry; D013696:Temperature
chemical_list: D000631:Aminopyridines; D008823:Micelles; D012997:Solvents; D013607:Tablets; D012967:Sodium Dodecyl Sulfate; C045742:amlexanox
keywords: Amlexanox; bioadhesive buccal tablets; content uniformity testing; spectrofluorimetric