Bioequivalence of ambroxol in ambroxol hydrochloride and clenbuterol hydrochloride granules

Objective To develop an LC-MS/MS method for the determination of ambroxol in the plasma and evaluate the bioequivalence of ambrocol granules and ambrocol oral solution.Methods A single oral dose of ambrocol granule(test preparation,T) and ambrocol oral solution(reference preparation,R) was administered to 18 healthy volunteers in a randomized crossover study,and the pharmacokinetics and bioavailability were studied.Results The main pharmacokinetic parameters of ambrocol(T and R) were as follows:Cmax was(183.86±108.22) and(216.68±198.50)μg·L-1;tmax was(2.1±0.8) and(2.2±1.0)h;AUC0~96 was(2 274.13±1 159.02) and(2 016.97±928.48)μg·h·L-1;AUC0~∞ was(2 307.42±1 203.33) and(2 056.64±961.25)μg·h·L-1;t1/2 was(14.4±4.6) and(17.2±6.9)h.The relative bioavailability of ambrocol of preparation T was(111.3±18.0)% when compared with tablet R.Conclusion Statistic analysis shows no significant difference between the two preparations,and bioequivalence is observed.