title: Derivative emission spectrofluorimetry: Application to the analysis of newly approved FDA combination of ibuprofen and famotidine in tablets.
abstract: A new combination of ibuprofen (NSAID) and famotidine (H2 receptor antagonist) was recently approved by the FDA. It was formulated to relief pain while decreasing the risk of ulceration, which is a common problem for patients receiving NSAID. A rapid and simple derivative emission spectrofluorimetric method is proposed for the simultaneous analysis of this combination in their pharmaceutical preparation. The method is based upon measurement of the native fluorescence intensity of the two drugs at λex = 233 nm in acetonitrile. The emission data were differentiated using the first (D1) derivative technique. The plots of derivative fluorescence intensity versus concentration were rectilinear over a range of 2-35 and 0.4-8 µg/mL for both ibuprofen (IBU) and famotidine (FAM), respectively. The method was sensitive as the limits of detection were 0.51 and 0.12 µg/mL and limits of quantitation were 1.70 and 0.39 µg/mL, for IBU and FAM respectively. The proposed derivative emission spectrofluorimetric method was successfully applied for the determination of the two drugs in their synthetic mixtures and tablets with good accuracy and precision. The proposed method was validated as per ICH guidelines.
authors.affiliation: Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria, Egypt.
authors.forename: Marwa A A
authors.initials: MA
authors.lastname: Ragab
authors.affiliation: Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria, Egypt.
authors.forename: Eman I
authors.initials: EI
authors.lastname: El-Kimary
mesh_terms: D002138:Calibration; D004338:Drug Combinations; D015738:Famotidine / Q000032:analysis* / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D007052:Ibuprofen / Q000032:analysis* / Q000737:chemistry; D057230:Limit of Detection; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012997:Solvents; D013050:Spectrometry, Fluorescence / Q000379:methods*; D013607:Tablets / Q000032:analysis / Q000737:chemistry
chemical_list: D004338:Drug Combinations; D012997:Solvents; D013607:Tablets; D015738:Famotidine; D007052:Ibuprofen
keywords: FDA approved combination; famotidine; first derivative emission spectrofluorimetry; ibuprofen; tablets