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目的:建立超高效液相色谱-多波长检测法同时测定盐酸氨溴索口服溶液及糖浆中9种防腐剂。方法:色谱柱:AgilentZorbax Eclipse XDB C18色谱柱(50 mm×4.6 mm,1.8μm),流动相:乙腈-磷酸盐缓冲溶液,梯度洗脱,流速:1.5 mL·min-1,柱温:40℃。定量波长为各组分的最大吸收波长。通过改变磷酸盐缓冲液的pH,排除了样品中氨溴索主峰对测定的干扰。结果:9种防腐剂分离完全,峰形良好。在2～100μg·mL-1的浓度范围内线性关系良好(r≥0.999),精密度RSD<2.0%,平均加样回收率为98%～102%。结论:该方法简单快速,分离效果好,可用于盐酸氨溴索口服液体制剂中防腐剂的筛查和定量测定。
Objective: To establish a simultaneous determination of 9 preservatives in ambroxol hydrochloride oral solution and syrup by ultra performance liquid chromatography with multiple wavelength detection. Methods: The column was Agilent Zorbax Eclipse XDB C18 (50 mm × 4.6 mm, 1.8 μm). The mobile phase consisted of acetonitrile-phosphate buffer solution with gradient elution at a flow rate of 1.5 mL · min -1. The column temperature was 40 ℃ . Quantitative wavelength for each component of the maximum absorption wavelength. By changing the pH of the phosphate buffer, interference with the determination of the main peak of ambroxol in the sample was excluded. Results: Nine kinds of preservatives were completely separated and their shape was good. The linearity was good (r≥0.999) in the range of 2 ~ 100μg · mL-1, the RSD of precision was less than 2.0% and the average recovery was 98% ~ 102%. Conclusion: The method is simple and rapid, the separation effect is good, and can be used for the screening and quantitative determination of preservatives in ambroxol hydrochloride oral liquid preparation.