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/Title ({In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS})
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2017
Maja Vujovic
Milan Jokanovic
Goran Nikolic
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 min 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.
{In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS}
bibtex/url/http://www.doiserbia.nb.rs/Article.aspx?ID=0367-598X1600020V
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Article
Maja Vujovic
Milan Jokanovic
Goran Nikolic
Vujovic2017
10.2298/HEMIND160315020V
:C$backslash$:;:HI_No1_2017_www\\HEMIND_Vol71_No1_75-83_Jan-Feb_2017.pdf:PDF
Hemijska industrija
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{In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS}
http://www.doiserbia.nb.rs/Article.aspx?ID=0367-598X1600020V
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