Simultaneous determination of roxithromycin and ambroxol hydrochloride in a new tablet formulation by liquid chromatography.

摘要

A rapid and accurate liquid chromatographic method is described for the simultaneous determination of roxithromycin and ambroxol hydrochloride in a new tablet formulation. Chromatographic separation of the two drugs was achieved on a Diamonsil trade mark C(18) column ( [Formula: see text] mm, 5microm). The mobile phase consisting of a mixture of acetonitrile, methanol and 0.5% ammonium acetate (39:11:50 (v/v), pH 5.5) was delivered at a flow rate of 1.0ml/min. Detection was performed at 220nm. Linearity, accuracy and precision were found to be acceptable over the concentration range of 201.2-2012.0microg/ml for roxithromycin and 42.7-427.0microg/ml for ambroxol hydrochloride, respectively. Separation was complete in less than 10min. The proposed method can be used for the quality control of formulation products.