Determination of size and size distribution of leuprorelin acetate microspheres for injection using laser diffraction method
GUO Ning-zi
XIN Zhong-shuai
SUN Yue
YANG Hua-xin
Abstract：Objective:To explore the critical influencing factors on determination of the size distribution of leuprorelin acetate microspheres for injection using laser diffraction method and develop an optimal test method of size and size distribution of microsphere formulation.Methods:The optimal conditions were determined by exploring the agitation speed,agitation time,ultrasonication time,sample concentration and suspending agent.20 mg microspheres were added into 1 mL suspending agent to form a homogeneous dispersed solution.After pouring the above suspension into the sample cell and conducting ultrasonication for 1 minute,replicated measurements were carried out with agitation speed at 2 200 r· min-1.Results:Conditions including ultrasonication,agitation speed,agitation time had significant influence on the size distribution of microspheres.The developed method was used to determine the size and size distribution of sample A,B and C.The sizes and size distribution of sample A and B were similar,which differed from sample C.Conclusion:The established method with the optimal test conditions can be employed to facilitate the quality control of leuprorelin acetate microspheres for injection.
Keywords：leuprorelin acetate microspheres for injectionsize and size distributionlaser diffraction method
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 886-892 )