HPLC法同时测定脂质体制剂中沙美特罗和布地奈德的含量  

Simultaneous HPLC determination of salmeterol and budesonide in liposome preparation

作　　者：王志宣[1] 邓英杰[1] 张晓鹏[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《药物分析杂志》2007年第2期231-233,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立同时测定脂质体制剂中沙美特罗和布地奈德含量的 HPLC 方法。方法:采用 Hypersil C_(18)色谱柱(250 mm×4.6 mm,5μm),在1000 mL 甲醇-乙腈-水(55:15:30)中加入冰醋酸0.7 mL 和三乙胺0.5 mL 为流动相,流速为1.0 mL·min^(-1),检测波长为225 nm。结果:沙美特罗和布地奈德线性范围分别为10～200μg·mL^(-1)(r=0.9997)和20～400μg·mL^(-1)(r=0.9999),回收率分别为99.9%和99.8%,重复性试验 RSD 均小于1%。结论:本方法准确、简便、快速,可用于沙美特罗、布地奈德脂质体制剂的质量控制。Objective：To establish an HPLC method for simultaneous determination of salmeterol and budesonide in liposome preparation. Method ：The chromatographic separation was performed on a Hypersil column （250 mm × 4. 6 mm,5 μm） with UV detection at 225 nm by isocratic elution of mobile phase with flow rate of 1.0 mL · min^-1. The mobile phase was consisted of methol - acetonitrile - water （55： 15： 30） ,0. 7 mL glacial acetic acid and 0. 5 mL triethylamine were added to 1000 mL mobile phase. Results： Salmeterol and budesonide were well separated. The calibration curve was linear （ r = 0. 9997 ） within the range of 10 - 200 μg·mL^-1 for salmeterol, the aver- age recovery was 99. 9%. The calibration curve was linear （r =0. 9999） in the range of 20 -400 μg·mL^-1 for budesonide,the average recovery was 99. 8%. The RSD of repeatability was under 1% for salmeterol and budesonide. The detection levels were estimated to be 5.0 ng and 8.0 ng monitored at 225 nm for salmeterol and budesonide respectively. Conclusion：The described method is accurate, rapid and can be conveniently applied for routine quality control analysis of liposome salmeterol and budesonide.

关 键 词：沙美特罗 布地奈德 脂质体 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]