Development and validation of a method for the simultaneous determination of ambroxol and clenbuterol in syrup by high resolution liquid chromatography

The combination of ambroxol and clenbuterol, as active principles, have a complementary action, by combining a bronchodilator (clenbuterol) and an expectorant and mucolytic (ambroxol), this combination is designed to facilitate the elimination of excess mucus and phlegm, helping to open the respiratory tract in those acute and chronic diseases of the respiratory tract that are accompanied by bronchospasm and pathological alteration of the formation and transport of the secretion, especially spasmodic bronchitis, COPD and bronchial asthma.There are no reported validated methods for the simultaneous determination of both components in syrup-type formulations; Due to the fact that validated analytical methods are of vital importance for the assurance of the composition of the drug as a requirement for its commercialization, it was proposed to develop and validate an analytical procedure by HPLC for the simultaneous determination of ambroxol hydrochloride and clenbuterol in syrups.
The method was developed and subsequently validated according to the requirements established in section <1225> of USP category I, for the quantification of major drug components in finished pharmaceutical products.
The chromatographic conditions were the following: L1 (C18), mobile phase: acetonitrile, methanol, buffer / ionic pair (KH₂PO₄ and 1-octanesulfonic acid) (15:20:65)% v / v at pH 3.70, flow of 1.5 mL / min mobile phase, injection volume = 15 µL and wavelength = 245 nm
The results obtained in this work show that the proposed method is precise, accurate, selective, robust and reliable under the proposed analysis conditions.