摘要
目的:建立测定吉非替尼原料药的粒度及其分布的方法,并进行方法学验证。方法:采用Malvern Mastersizer 3000激光粒度分析仪和Hydro LV湿法进样器,以光散射法测定吉非替尼原料药的粒度分析并进行方法学考察,泵速为2 000 r·min^(-1),遮光比为8%~20%,背景与样品的扫描时间为10 s,样品折射率为1.500,样品吸光率为0.00。结果:3批吉非替尼原料药的D_(10)均小于7μm,D_(50)均小于15μm,D90均小于25μm,符合制剂终产品生产的需求。结论:该方法准确、简便、重复性好,适用于吉非替尼原料药的粒度分析。
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 D_（10） of 3 batches of gefitinib was less than 7 μm,the D_（50） was less than 15 μm and the D_（90） 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.
出处
《中国药师》
CAS
2016年第5期876-879,共4页
China Pharmacist
关键词
粒度分析
激光粒度分析仪
吉非替尼
Particle size analysis
Laser scattering method
Gefitinib
