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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 a HPLC method for the determination of two components and the content of preservatives in dextromethorphan hydrobromide syrup. Methods: Agilent Zobax SB-C18 (250 mm × 4.6 mm, 5 μm) column was used. Methanesulfonic acid solution (4.8 g of methanesulfonic acid, 750 ml of water and 10 ml of triethylamine was added. The pH value was adjusted to 3.5 with phosphoric acid ) -acetonitrile (75:25) as mobile phase. The detection wavelength was 280 nm. The column temperature was 30 ℃. The flow rate was 1.0 ml · min-1. The injection volume was 20 μl. Results: The linear relationship between guaifenesin at 102 ~ 1025μg · ml-1, dextromethorphan hydrobromide at 15 ~ 619μg · ml-1 and benzoic acid at 10 ~ 407μg · ml-1 was good. Rates were 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 can be used for the quality control of compound dextromethorphan hydrobromide syrup.