帕博西尼的粒度激光散射测定方法的建立和验证

Establishment and verification of particle size test method of palbociclib by laser light scattering

目的:建立激光散射法测定帕博西尼原料药的粒度分布。方法:采用Malvern Mastersizer 3000型激光粒度分析仪,干法测定模式,标准文丘里管,样品折射率1.52,样品吸收率0.01,遮光度0.5%～5.0%,背景和测定扫描时间5 s,气源压力0.15 MPa,进料速度40%,狭缝宽度1.5 mm,测定次数5次。结果:d(0.5)值的RSD均小于3%,d(0.1)和d(0.9)值的RSD均小于5%。结论:本法可用于测定帕博西尼原料药的粒度。

Objective:To establish a laser light scattering method for the determination of particle size distribution of palbociclib. Methods:A Malvern Mastersizer 3000 type laser size analyzer was used with a model of dry determination and standard venture tube. Determination conditions were selected as follows:sample refractive index of 1.52,sample absorbency of 0.01,shading degree of 0.5%-5.0%,measurement time for background and samples of 5 s,air press of 0.15 MPa,feed rate of 40%,slit width of 1.5 mm,measurement for 5 times. Results:The RSDs of methodological study for d(0.5)values were lower than 3%,and lower than 5% for both d(0.1)and d(0.9)values. Conclusion: The established method can be used for the detection of particle size distribution of palbociclib.