RAPID AND SIMPLE DETERMINATION OF IBUPROFEN AND CAFFEINE IN FIXED-DOSE COMBINATION FORMULATIONS: APPLICATION TO DISSOLUTION STUDIES

  • Jose Raúl Medina-López Departamento Sistemas Biologicos, Universidad Autonoma Metropolitana-Xochimilco, Mexico City http://orcid.org/0000-0002-4159-8403
  • Joaquín Alexandro Soto-Juha Departamento Sistemas Biologicos, Universidad Autonoma Metropolitana-Xochimilco, Mexico City
  • Juan Manuel Contreras-Jiménez Departamento Sistemas Biologicos, Universidad Autonoma Metropolitana-Xochimilco, Mexico City

Abstract

determinations for the simultaneous quantification of ibuprofen (IBU) and caffeine (CAF) in fixed-dose combination formulations (soft gelatin capsules). The proposed method was validated, and it was applied to determine the in vitro dissolution performance of IBU and CAF from a commercial formulation.


Methods: The method is based on the use of the second-derivatives of the zero-order spectra and measurement at zero-crossing wavelengths. Linearity, accuracy, precision, stability, and influence of the filter were evaluated. Dissolution profiles of IBU and CAF were obtained with the USP Apparatus 2 at 100 rpm and 900 ml of 0.1 M phosphate buffer pH 7.4 as dissolution medium. Dissolution samples were treated with the proposed UV-derivative method and results were compared with data previously published.


Results: The zero-crossing points for determination of IBU and CAF were found at 235.6 nm and 218.8 nm, respectively. The method was linear in the range of 7.5-15 µg/ml for IBU and 5-25 µg/ml for CAF (R2>0.999, *P<0.05). The precision and accuracy of the method were within acceptable criteria (CV<0.99% and recovery 97.97% for IBU and CV<1.76% and recovery 99.05% for CAF). Fiberglass filters were the best option to filter samples and stability of all drugs was adequate when solutions were stored at 25ºC during 24 h. Dissolution of IBU and CAF at 60 min was 99-100% with dissolution profiles of sigmoidal S-shape. Weibull function and logistic were the best-fit models that describe the in vitro dissolution performance of both drugs.


Conclusion: The proposed UV-derivative method allows the simultaneous determination of IBU and CAF in fixed-dose combination formulations. The method generates reliable information that can be compared with published data. The proposed UV-derivative method is rapid and simple and can be easily adopted for routine analysis of IBU and CAF.

Keywords: caffeine, derivative spectroscopy, ibuprofen, USP Apparatus 2

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Medina-López, J. R., Soto-Juha, J. A., & Contreras-Jiménez, J. M. (2021). RAPID AND SIMPLE DETERMINATION OF IBUPROFEN AND CAFFEINE IN FIXED-DOSE COMBINATION FORMULATIONS: APPLICATION TO DISSOLUTION STUDIES. International Journal of Applied Pharmaceutics, 13(3). https://doi.org/10.22159/ijap.2021v13i3.40975
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