建立了HPLC法同时测定盐酸伪麻黄碱(2)/盐酸非索非那定(1)(下称伪麻非索)缓释胶囊中的1和2。采用Hypersil苯基柱(4.6 mm×250 mm,5?m),以甲醇∶0.01 mol/L磷酸二氢钾(用稀磷酸调至p H 3.2)(75∶25)为流动相,检测波长为215 nm。另外,采用Agilent SB苯基柱(4.6 mm×250 mm,5?m),以磷酸盐高氯酸盐缓冲液(p H 2.0)∶乙腈∶三乙胺(650∶350∶3)为流动相,在220 nm处测定1的有关物质A、C、D;采用Astec CyclobondTMⅠ2000柱(4.6 mm×250 mm,5?m),以乙酸盐缓冲液(p H 4.0)∶乙腈(85∶15)为流动相,在220 nm处测定1的有关物质B;采用Spherisorb氰基柱(4.6 mm×250 mm,5?m),以1.16%乙酸铵溶液∶甲醇(94∶6,用乙酸调至p H 4.0)为流动相,在257 nm处测定2的有关物质。上述色谱条件经方法学验证均符合规定。3批样品的加速和长期试验结果表明,外观、含量和释放行为均未发生明显变化,提示样品的质量较稳定。 A HPLC method was established for the simultaneous determination of 1 and 2 in pseudoephedrine hydrochloride (2) / fexofenadine hydrochloride (1) (pseudpiximabine) sustained release capsules. The mobile phase consisted of Hypersil phenyl column (4.6 mm × 250 mm, 5 μm), methanol: 0.01 mol / L potassium dihydrogen phosphate (adjusted to p H 3.2 with dilute phosphoric acid) (75:25) 215 nm. In addition, an Agilent SB phenyl column (4.6 mm × 250 mm, 5 μm) was used with a mobile phase of phosphate perchlorate buffer (p H 2.0): acetonitrile: triethylamine (650: 350: 3) , The relevant substances A, C, D of 1 at 220 nm were determined using an Astec Cyclobond ™ II2000 column (4.6 mm × 250 mm, 5 μm) in acetate buffer (p H 4.0): acetonitrile (85:15) As the mobile phase, the substance of interest B was measured at 220 nm; a Spherisorb cyano column (4.6 mm × 250 mm, 5 μm) was used with 1.16% ammonium acetate solution: methanol (94: 6, H 4.0) as the mobile phase, at 257 nm at the determination of 2 related substances. The above chromatographic conditions were verified by methodological compliance. Three batches of samples accelerated and long-term test results show that the appearance, content and release behavior did not change significantly, suggesting that the quality of the sample is more stable.