ABSTRACT
Objective:To establish and validate a method for the determination of particle size and size distribution of gefitinib. Methods:A Malvern Mastersizer 3000 laser size analyzer and a Hydro LV wet autosampler were used,a light scattering method for the determination of particle size and size distribution was adopted to analyze the particle size of gefitinib,and then the methodological study was carried out. The pump speed was 2 000 r·min -1 ,the obscuration was 8% -20% ,the measurement time of background and sample was 10 s,the sample RI was 1. 500,and the sample absorbance was 0. 00. Results:The D10 of 3 batches of gefitinib was less than 7 μm,the D50 was less than 15 μm and the D90 was less than 25 μm,which all met the preparation requirements of final products. Conclusion:The method is accurate,simple and repeatable,and suitable for the particle size analysis of gefitinib.