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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 a method for the determination of the particle size and distribution of gefitinib bulk drugs, and to verify the methodology. Methods: The particle size analysis of gefitinib bulk drug was determined by light scattering method with Malvern Mastersizer 3000 laser particle size analyzer and Hydro LV wet sampler. The pump speed was 2 000 r · min ~ (- 1), the shading ratio is 8% ~ 20%, the scanning time of the background and the sample is 10 s, the refractive index of the sample is 1.500, and the absorbance of the sample is 0.00. Results: The D_ (10) of three batches of gefitinib were all less than 7μm, D_ (50) were all less than 15μm and D90 were all less than 25μm, which accorded with the demand of the finished product. Conclusion: The method is accurate, simple and reproducible. It is suitable for the particle size analysis of gefitinib bulk drugs.