呋塞米粒度分布的激光散射测定方法的建立和验证  

Establishment and Validation of Particle Size Distribution Determination Method of Furosemide by Laser Light Scattering

作　　者：徐丽洁 张晓明 王勇军 桑泽廷 王彬 XU Li-jie;ZHANG Xiao-ming;WANG Yong-jun;SANG Ze-ting;WANG Bin(Jiangsu Yabang Aipusen Pharmaceutocal Co.,Ltd,Yancheng 224599,China;Changzhou Yabang Pharmaceutical Co.,Ltd.,Changzhou 213163,China)

机构地区：[1]江苏亚邦爱普森药业有限公司,江苏盐城224599 [2]常州亚邦制药有限公司,江苏常州213163

出　　处：《海峡药学》2024年第12期50-54,共5页Strait Pharmaceutical Journal

摘　　要：目的建立激光散射法湿法测定呋塞米原料药粒度分布并进行方法学验证。方法采用Malvern Mastersizer 3000型激光粒度分析仪,Hydro EV湿法进样器,分散介质为水,十二烷基硫酸钠作为分散剂。超声强度5%,超声时间4 min,搅拌速度2500 r·min^(-1),背景与样品测量时间10S。结果样品折射率1.658,样品吸收率0.01,遮光率8%~15%。方法学考察结果粒度分布值RSD(D 10)和RSD(D 90)均小于5%,RSD(D 50)小于3%。结论本方法准确、快速,重现性好,适合呋塞米原料药的粒度测定。OBJECTIVE To establish a laser light scattering method(wet)for the determination of particle size and distribution of Furosemide active pharmaceutical ingredient(API).METHODS The Malvern Mastersizer 3000 laser size analyzer with the Hydro EV wet autosampler were used.Dispersion medium was water.Dispersant was sodium dodecyl sulfate.Samples were evenly dispersed by ultrasonic(5%)for 4 min.Stirring speed was 2500 r·min^(-1).Measurement time for background and specimen were 10 s.RESULTS Particle refractive index was 1.658,granule absorbency was 0.01,laser obscuration was 8%-15%.The RSD of D 10 and D 90 were all less than 5%,and RSD of D 50 was less than 3%.CONCLUSION The method is accurate,fast and repeatable.It is suitable for the particle size determination of Furosemide API.

关 键 词：激光散射法 粒度分布 方法研究 呋塞米 湿法测定 

分 类 号：R927[医药卫生—药学]