高效液相色谱法测定雷登泰口服液中愈创木酚甘油醚、盐酸伪麻黄碱、氢溴酸右美沙芬的含量  

HPLC Determination of Guaifenesin,Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide in Redentai Oral Solution

作　　者：李永庆[1] 田子新[1] 赵文[1] 朱霁虹[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2000年第2期97-99,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的 :采用高效液相色谱外标法测定雷登泰口服液中愈创木酚甘油醚、盐酸伪麻黄碱、氢溴酸右美沙芬的含量。方法 :色谱柱为SpherisorbC85 μm　 4 6mm× 2 5 0mm ,流动相为 0 0 0 2 5mol·L-1己烷磺酸甲醇溶液 -水 (含 2 %三乙胺 ) - 3mol·L-1磷酸 ( 1 4∶1∶0 0 63 ) ,紫外检测器 ,检测波长 2 5 7nm。结果 :愈创木酚甘油醚进样量在 2 0～ 10 0 μg ,盐酸伪麻黄碱在 0 3～ 1 5 μg ,氢溴酸右美沙芬在 0 15～ 0 65 μg范围内与峰面积呈良好的线性关系 ,相关系数依次为 0 9986,0 9999,0 9999,回收率依次为 10 0 8% ,10 0 5 % ,99 69%。结论 :本法精密度好 。Objective:To establish an external standard HPLC method for the determination of guaifenesin,pseudoephedrine hydrochloride and dextromethorphan hydrochloride in Redentai oral solution.Method: The chromatographic conditions were as follows: Spherisorb C 8 column(5 μm, 4 6 mm×250 mm),0 002 5 mol·L -1 1-hexane sulfonic acid methanolic solution-water (0 2% triethylamine)-0 3 mol·L -1 phosphoric acid(1 4∶1∶0 063)as the mobile phase and UV detector at 257 nm. Results: The calibration curves were linear in the range of 2 0～10 0 μg for guaifenesin( r =0 998 6),0 3～1 5 μg for pseudoephedrine hydrochloride( r = 0 999 9 ) and 0 15～0 65 μg for dextromethorphan hydrochloride( r= 0 999 9)respectively. The average recoveries( n=5) were 100 8% for guaifenesin( RSD =0 9%),100 5% for pseudoephedrine hydrochloride( RSD= 1 0%) and 99 7% for dextromethorphan hydrobromide ( RSD =1 2%). Conclusion:The method is rapid, accurate and reliable for the quality control of redentai oral solution.

关 键 词：雷登泰口服液 愈创木酚甘油醚 伪麻黄碱 HPLC 

分 类 号：R971.1[医药卫生—药品] R927.2[医药卫生—药学]