title: Simultaneous determination of roxithromycin and ambroxol hydrochloride in a new tablet formulation by liquid chromatography.
abstract: 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 C(18) column (200 mm x 4.6 mm, 5 microm). 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 1.0 ml/min. Detection was performed at 220 nm. Linearity, accuracy and precision were found to be acceptable over the concentration range of 201.2-2012.0 microg/ml for roxithromycin and 42.7-427.0 microg/ml for ambroxol hydrochloride, respectively. Separation was complete in less than 10 min. The proposed method can be used for the quality control of formulation products.
authors.affiliation: Department of Chemistry, School of Chemical Engineering and Materials Science, Beijing Institute of Technology, Beijing 100081, PR China. mlqi@bit.edu.cn
authors.forename: Meiling
authors.initials: M
authors.lastname: Qi
authors.forename: Peng
authors.initials: P
authors.lastname: Wang
authors.forename: Ruihua
authors.initials: R
authors.lastname: Cong
authors.forename: Jianjun
authors.initials: J
authors.lastname: Yang
mesh_terms: D000551:Ambroxol / Q000032:analysis*; D000900:Anti-Bacterial Agents / Q000032:analysis; D002853:Chromatography, Liquid / Q000295:instrumentation / Q000379:methods; D004338:Drug Combinations; D005100:Expectorants / Q000032:analysis; D015203:Reproducibility of Results; D015575:Roxithromycin / Q000032:analysis*; D013607:Tablets / Q000737:chemistry
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005100:Expectorants; D013607:Tablets; D000551:Ambroxol; D015575:Roxithromycin