帕博昔布原料药粒径的激光散射法测定

Application of Laser Particle Size Analyzer in Measurement of Palbociclib Partical Size Distribution

建立了激光散射法测定帕博昔布原料药的粒径及其分布。采用Malvern Mastersizer 3000型激光粒度分析仪,Hydro MV湿法进样器。帕博昔布在水中易团聚,需加入适当的分散剂来促进粒子在水中的均匀分散。设定参数为:搅拌速度2 000 r/min,遮光度10%~17%,背景与样品的测量时间10 s,样品折射率1.48,吸光率0.01。该法准确、简便、重复性好,可用于帕博昔布原料药的粒径分析。

An experimental method was established for the measurement of the particle size distribution of palbociclib using laser particle size analyzer. A Malvern Mastersizer 3000 type laser size analyzer and a Hydro MV wet autosampler were used. In this paper, the influences of refractive index, dispersant＇s dosage, shading degree, stirrer speed and measurement time on the measurement result of the particle size distribution of palbociclib were systematically studied. The experimental results showed that palbociclib tended to agglomerate in water, and an appropriate dispersant must be added to promote the particles to disperse evenly. The determination conditions were determined as follows： pump speed of 2 000 r/min, shading degree of 10%--17%, measurement time for background and samples of 10 s, sample refractive index of 1.48, and sample absorbency of 0.01. The method is accurate, simple, repeatable and suitable for the particle size analysis of palbociclib.