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Ambroxol hydrochloride is an expectorant agent, successfully applied in   mucolytic therapy for acute and chronic bronchopulmonary diseases. The drug   regulates not only mucus secretion but also showed antioxidant,   anti-inflammatory and local anesthetic properties. To supplement the   pharmacokinetic and toxicological studies of ambroxol, a rapid ultra-high   performance liquid chromatography-tandem mass spectrometry method for the   quantitation of ambroxol in rabbit serum was developed. A validation of the   method was performed as per the ICH guidelines for the validation of   bioanalytical methods. The chromatographic separation was achieved in a   submicron Kinetex RP - C18 - column (2.1 mm x 50 mm, 1.3μm) using the no   buffer mobile phase. The ESI mass spectrometry in the MRM mode was used with   a typical transitions m/z 378.9→263.8 for ambroxol and m/z 455.2→165.0 for   IS. Linearity was determined with an average coefficient of determination   >0.999 over the dynamic range from 0.5 - 200 ng/mL with LOD and LOQ of 0.25   ng/mL and 0.5 ng/mL, respectively. The results of the intra- and inter-day   precision and accuracy determined in different days were all found to be   within the acceptable limits ±15%. The present method was successfully   applied to pharmacokinetic study in the rabbits after a single oral dose   administration. [Projekat Ministarstva nauke Republike Srbije, br. 175045

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Development of a new ultra-high performance liquid chromatography - tandem mass spectrometry method for determination of ambroxol hydrochloride in serum with pharmacokinetic application