帕博西尼的粒度激光散射测定方法的建立和验证

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.

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