Dissolution test study of salmeterol xinafoate and fluticasone propionate powder for inhalation
WANG Ting
ZHOU Ying
SUN Chun-meng
WEI Ning-yi
Abstract：Objective:In this study,salmeterol ticasone inhalation powder aerosol was used as the research object to develop a dissolution detection method,and the particle size of the drug powder was graded by next generation impactors(NGI),and the dissolution of the drug particles deposited in the second level of NGI was studied by taking the fine particle size drug that can be deposited in the human lungs,and the paddle method.Methods:High performance liquid chromatography-tandem mass spectrometry(LC-MS/MS)was used to determine the concentrations of salmeterol and fluticasone propionate and plot the dissolution curves.Results:Salmeterol had a good linear relationship between 1.8～10.79 ng·mL-1 and fluticasone propionate in the concentration range of 6.51～39.06 ng·mL-1,the correlation coefficient was greater than 0.995,the precision,stability and repeatability were good,the recovery rate of salmeterol spike was 90％～94％,and the recovery rate of fluticasone propionate spiked was 92％～100％.Conclusion:This method is robust and reliable,and is suitable for the determination of dissolution of salmeterol ticasone inhalation powder aerosol.
Keywords：salmeterol xinafoate and fluticasone propionate powder for inhalationdissolutionnext generation impactors
Publication Date：2025-04-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 857-862 )