HPLC法测定盐酸氨溴索口服液体制剂中防腐剂含量

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:Agilent Zorbax Eclipse XDB C₁₈色谱柱(50 mm× 4.6 mm,1.8 μm),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2~100 μg·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 high performance liquid chromatography-diode array detection (HPLC-DAD) method to simultaneously determine nine kinds of preservatives in ambroxol hydrochloride oral solution and syrup. Methods: The method was conducted on an Agilent ZORBAX Eclipse XDB C₁₈ column (50 mm×4.6 mm,1.8 μm) with phosphate buffered solution and acetonitrile as mobile phase,by gradient elution at a flow rate of 1.5 mL·min^-1.The column temperature was set at 40 ℃.The interference of impurity peaks was eliminated by adjusting the pH of buffer solution in the mobile phase.The quantitative wavelength was the maximum absorption wavelength of each component. Results: Complete separation of nine kinds of preservatives was achieved with fine peak shapes.The calibration curves were linear in the range of 2-100 μg·mL^-1(r≥0.999).The average recoveries were between 98% and 102%,and the RSD was less than 2%. Conclusion: The method was convenient,rapid,with good separation,which can be used for screen and quantitatively determination of preservatives in ambroxol hydrochloride oral liquid preparations.

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