高效液相色谱法测定扎那米韦粉雾剂的含量及其体外有效部位沉积率  

HPLC determination and in vitro deposition of zanamivir dry powder inhalation

作　　者：郭娜[1,2] 杨阳[2] 王思玲[1] 梅兴国[2] 

机构地区：[1]沈阳药科大学,沈阳110016 [2]军事医学科学院毒物药物研究所,北京100850

出　　处：《中国新药杂志》2013年第4期408-410,442,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2009ZX09301-002)

摘　　要：目的:建立高效液相色谱法测定扎那米韦粉雾剂肺部沉积率的方法。方法:采用SCX色谱柱(250 mm×4.6 mm,5μm),流动相为乙睛-0.02 mol.L-1醋酸盐缓冲液(pH=3.7)(60∶40),检测波长为234 nm。结果:在20.0～300.0μg.mL-1范围内,峰面积对质量浓度有良好的线性关系,日内精密度和日间精密度均小于2%(n=5);回收率在98%～102%之间。结论:本法精密准确,适用于扎那米韦粉雾剂肺部沉积率的测定。Objective： To establish an HPLC method to determine the content and in vitro deposition of zanamivir dry powder inhalation. Methods： A column packed with Luna SCX （250 mm × 4.6 mm, 5 μm, phenomenex） was used. The mobile phase was acetonitrile （pH 3.7） ： acetate buffer （60： 40） and the flow rate was 1 mL·min^-1. The UV detection wavelength was set at 234 nm. Results： The calibration curve was linear in the range of 20.0 to 300.0 μg·mL^-1. The average recovery was within 98% - 102% , repeatability and intermediate precision RSD was less than 2%. Conclusion： The established HPLC method is sensitive and reliable, and suitable for the quantification of zanamivir dry powder inhalation.

关 键 词：扎那米韦 粉雾剂 含量 体外有效部位沉积率 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学] R978.7