In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS
| Autor: | Vujović Maja M., Jokanović Milan, Nikolić Goran M. |
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| Jazyk: | English<br />Serbian |
| Rok vydání: | 2017 |
| Předmět: | |
| Zdroj: | Hemijska Industrija, Vol 71, Iss 1, Pp 75-83 (2017) |
| Druh dokumentu: | article |
| ISSN: | 0367-598X 2217-7426 |
| DOI: | 10.2298/HEMIND160315020V |
| Popis: | In this paper a simplified dissolution test was performed for the release of ambroxol from tablets according to the European Pharmacopoeia. In vitro, three different dissolution media; 0.1 M HCl pH 1.2, acetate buffer (ABS) pH 4.5 and phosphate buffer (PBS) pH 6.8 were used for the simulation of the gastrointestinal conditions at temperature of 37.0±0.5°C. The drug release was evaluated by a new ultra - high performance liquid chromatography (UHPLC) - tandem mass spectrometry (MS/MS) method. The method was validated to meet requirements as per ICH guidelines which include linearity, specificity, precision, accuracy and robustness. The corresponding dissolution profiles showed more than 80% drug release within 30 minutes without significant differences. Further, the developed and validated UHPLC-MS/MS method could find a useful application in the process of production, quality control and bioavailability/bioequivalence studies of new pharmaceutical formulations of drugs in order to achieve a safe therapeutic efficacy. [Projekat Ministarstva nauke Republike Srbije, br. 175045] |
| Databáze: | Directory of Open Access Journals |
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