Development of a new ultra-high performance liquid chromatography - tandem mass spectrometry method for determination of ambroxol hydrochloride in serum with pharmacokinetic application
2016
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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