愈美缓释片中愈创木酚甘油醚、氢溴酸右美沙芬含量运用HPLC测定分析报告

摘要

Objective To establish a method for the determination of dextromethorphan hydrobromide and guaifenesin in Yumei Sustained-release tablets.Methods HPLC C18 column was used as fixed phase.Mobile phase was consist of triethylamine phosphate solution,which was adjusted with phosphoric acid to pH3.0,and the mixture of acetonitrile and methanol.The detective wavelengths were at 246nm between 0 and 6 minutes,and at 218nm after 6 minutes.Results The calibration curves for dextromethorphan hydrobromide and guaifenesin were linear over the range of 0.1996 ~ 1.1976mg/mL,0.015024 ~ 0.09014mg/mL.The recoveries were 99.7% and 100.9% with RSD 1.5% and 1.4%,respectively.Conclusion This method is simple,rapid,accurate and reproducible.%目的 分析高效液相色谱法(HPLC)测定愈美缓释片中愈创木酚甘油醚和氢溴酸右美沙芬含量的特点.方法 高效液相色谱法C18柱固定相,流动相:磷酸三乙胺溶液(3mL三乙胺加入1,000mL蒸馏水中,以磷酸调pH=3.0):(乙腈:甲醇=4:3)=60:40;双波长检测:0～6min时246nm,6min以后218nm.结果 愈创木酚甘油醚和氢溴酸右美沙芬线性范围分别为0.1996～1.1976 mg/mL、0.015024～0.09014mg/mL;回收率分别为99.7%、100.9%;RSD分别为1.5%、1.4%.结论 临床实践中HPLC可以简单、快速、准确分析愈美缓释片中主要成分含量.