In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS
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 simulati...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Association of Chemical Engineers of Serbia
2017-01-01
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| Series: | Hemijska Industrija |
| Subjects: | |
| Online Access: | http://www.doiserbia.nb.rs/img/doi/0367-598X/2017/0367-598X1600020V.pdf |
| Summary: | 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] |
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| ISSN: | 0367-598X 2217-7426 |