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...
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| Format: | Article |
| Language: | English |
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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 |
| _version_ | 1819200457178873856 |
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| author | Vujović Maja M. Jokanović Milan Nikolić Goran M. |
| author_facet | Vujović Maja M. Jokanović Milan Nikolić Goran M. |
| author_sort | Vujović Maja M. |
| collection | DOAJ |
| description | 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] |
| first_indexed | 2024-12-23T03:32:32Z |
| format | Article |
| id | doaj.art-72559091c9834a9cbb0a0880e41afd29 |
| institution | Directory Open Access Journal |
| issn | 0367-598X 2217-7426 |
| language | English |
| last_indexed | 2024-12-23T03:32:32Z |
| publishDate | 2017-01-01 |
| publisher | Association of Chemical Engineers of Serbia |
| record_format | Article |
| series | Hemijska Industrija |
| spelling | doaj.art-72559091c9834a9cbb0a0880e41afd292022-12-21T18:01:37ZengAssociation of Chemical Engineers of SerbiaHemijska Industrija0367-598X2217-74262017-01-01711758310.2298/HEMIND160315020V0367-598X1600020VIn vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MSVujović Maja M.0Jokanović Milan1Nikolić Goran M.2Faculty of Medicine, Niš + Institute of Forensic Medicine, Toxicology Laboratory, NišFaculty of Medicine, NišFaculty of Medicine, NišIn 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]http://www.doiserbia.nb.rs/img/doi/0367-598X/2017/0367-598X1600020V.pdfambroxoldissolution testUHPLC-MS/MS |
| spellingShingle | Vujović Maja M. Jokanović Milan Nikolić Goran M. In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS Hemijska Industrija ambroxol dissolution test UHPLC-MS/MS |
| title | In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS |
| title_full | In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS |
| title_fullStr | In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS |
| title_full_unstemmed | In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS |
| title_short | In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS |
| title_sort | in vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by uhplc ms ms |
| topic | ambroxol dissolution test UHPLC-MS/MS |
| url | http://www.doiserbia.nb.rs/img/doi/0367-598X/2017/0367-598X1600020V.pdf |
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