Heinänen M, Barbas C
Laboratory of Analytical Chemistry, University of Helsinki, Helsinki, Finland.
J Pharm Biomed Anal. 2001 Mar;24(5-6):1005-10. doi: 10.1016/s0731-7085(00)00533-1.
A method is described for ambroxol, trans-4-(2-amino-3,5-dibromobenzylamino) cyclohexanol hydrochloride, and benzoic acid separation by HPLC with UV detection at 247 nm in a syrup as pharmaceutical presentation. Optimal conditions were: Column Symmetry Shield RPC8, 5 microm 250 x 4.6 mm, and methanol/(H(3)PO(4) 8.5 mM/triethylamine pH=2.8) 40:60 v/v. Validation was performed using standards and the pharmaceutical preparation which contains the compounds described above. Results from both standards and samples show suitable validation parameters. The pharmaceutical grade substances were tested by factors that could influence the chemical stability. These reaction mixtures were analysed to evaluate the capability of the method to separate degradation products. Degradation products did not interfere with the determination of the substances tested by the assay.
描述了一种通过高效液相色谱法（HPLC）在247nm处进行紫外检测，以糖浆剂作为药物制剂形式分离氨溴索（盐酸氨溴索，反式-4-(2-氨基-3,5-二溴苄基氨基)环己醇）、苯甲酸的方法。最佳条件为：Symmetry Shield RPC8柱，5μm，250×4.6mm，流动相为甲醇/（8.5mM磷酸/三乙胺，pH = 2.8），体积比40:60。使用标准品和含有上述化合物的药物制剂进行了方法验证。标准品和样品的结果均显示出合适的验证参数。对药用级物质进行了可能影响化学稳定性的因素测试。对这些反应混合物进行分析，以评估该方法分离降解产物的能力。降解产物不干扰所测物质的含量测定。
