Dissolution method for delapril and manidipine combination tablets based on an absorption profile of manidipine
| Autor: | Maximiliano da Silva Sangoi, Gustavo Krumel Goelzer, Jaison C. Machado, Bibiana Verlindo de Araújo, Nadia Maria Volpato, Clésio S. Paim, Vítor Todeschini |
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| Rok vydání: | 2016 |
| Předmět: |
Absorption (pharmacology)
Accuracy and precision Pharmaceutical Science Delapril Pharmacy 030226 pharmacology & pharmacy 01 natural sciences Dosage form Analytical Chemistry 03 medical and health sciences Manidipine 0302 clinical medicine Drug Discovery Validation Electrochemistry medicine Dissolution Spectroscopy Medicine(all) Chromatography Chemistry Biochemistry Genetics and Molecular Biology(all) 010401 analytical chemistry lcsh:RM1-950 0104 chemical sciences Bioavailability lcsh:Therapeutics. Pharmacology Pharmaceutics Original Article medicine.drug in vivo-in vitro correlation |
| Zdroj: | Journal of Pharmaceutical Analysis, Vol 6, Iss 1, Pp 49-55 (2016) Journal of Pharmaceutical Analysis |
| ISSN: | 2095-1779 |
| DOI: | 10.1016/j.jpha.2015.10.002 |
| Popis: | The present study describes the development and validation of a dissolution method for delapril (DEL) and manidipine (MAN) combination tablets, using a simulated absorption profile based on in vivo data for MAN. The suitable in vitro dissolution profile for this formulation was obtained using 900 mL of citrate buffer pH 3.2 at 37 °C±0.5 °C as dissolution medium and USP apparatus 2 (paddle) at 75 rpm. All samples were analyzed by a liquid chromatography (LC) method. Under these conditions, a significant linear relationship between the absorbed (calculated by deconvolution approach) and dissolved fractions of MAN was obtained (R=0.997) and an in vivo-in vitro (IVIV) correlation for this particular formulation containing MAN can be established. Validation parameters for dissolution methodology such as the specificity, linearity, accuracy and precision were also evaluated according to the international guidelines, giving results within the acceptable range. Therefore, the proposed dissolution conditions can be applied for the simultaneous release analysis of DEL and MAN from the solid dosage form, contributing to the improvement of the quality control of pharmaceutics and minimizing the number of bioavailability studies. |
| Databáze: | OpenAIRE |
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