HPLC法测定复方氢溴酸右美沙芬糖浆中2组分及防腐剂的含量

Determination of Two Components and Preservative in Compound Dextromethorphan Hydrobromide Syrups by HPLC

目的：建立HPLC法测定复方氢溴酸右美沙芬糖浆中2组分及防腐剂的含量。方法：采用Agilent Zobax SB-C18（250mm×4.6 mm,5μm）柱;以甲烷磺酸溶液（取甲烷磺酸4.8 g,加水750 ml,加三乙胺10 ml,用磷酸调节p H值至3.5）-乙腈（75∶25）为流动相;检测波长为280 nm;柱温为30℃;流速为1.0 ml·min^-1;进样量为20μl。结果：愈创甘油醚在102-1 025μg·ml^-1、氢溴酸右美沙芬在15-619μg·ml^-1、苯甲酸在10-407μg·ml^-1范围内,线性关系良好;平均回收率分别为100.0%（RSD=0.35%）、100.1%（RSD=0.77%）、100.8%（RSD=0.49%）。结论：本法简便、快速、准确,可用于复方氢溴酸右美沙芬糖浆的质量控制。

Objective： To establish an HPLC method for the determination of two components and the preservative in compound dextromethorphan hydrobromide syrups. Methods： An Agilent Zobax SB-C18column（ 250 mm × 4. 6 mm,5 μm） was used with methanesulfonic acid solution（ adding 4. 8g methanesulfonic acid and 10 ml triethylamine into 750 ml water,and adjusting the p H value to3. 5 by phosphoric acid）-acetonitrile（ 75∶ 25） as the mobile phase at the flow rate of 1. 0 ml·min^-1 and 280 nm as the detection wavelength. Results： The calibration curve was linear within the range of 102-1 025μg·ml^-1 for guaifenesin,15-619 μg ·ml^-1 for dextromethorphan hydrobromide and 10-407 μg·ml^-1 for benzoic acid. The average recovery of guaifenesin,dextromethorphan hydrobromide and benzoic acid was 100. 0%（ RSD = 0. 35%）,100. 1%（ RSD = 0. 77%） and 100. 8%（ RSD = 0. 49%）,respectively. Conclusion：The method is simple,rapid and accurate,and suitable for the quality assessment of compound dextromethorphan hydrobromide syrups.