In vitro dissolution profile study of mucolytic drug ambroxol hydrochloride from solid oral dosage form by UHPLC-MS/MS

Maja M. Vujović, Milan Jokanović, Goran M. Nikolić


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.


ambroxol, dissolution test, UHPLC-MS/MS.

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