光散射法测定兰索拉唑原料药粒度及粒度分布
Particle size and particle size distribution of lansoprazole raw materials were determined by light scattering method
张新芹 1周礼玲2
作者信息
- 1. 六安市市场监管综合行政执法支队,安徽六安 237000
- 2. 六安市食品药品检验中心,安徽六安 237000
- 折叠
摘要
目的 建立兰索拉唑原料药粒度及粒度分布测定方法.方法 采用光散射法,颗粒折射率为 1.57,颗粒吸收率为 0.1,振动进样速度为 60%,分散气压为 3.0 Bar,遮光度为 0.5%～6%.结果 该方法重复性好,6 次结果的RSD分别是:d(0.1)为 2.0%,d(0.5)为 2.1%,d(0.9)为 0.7%,D(4,3)为 0.7%;中间精密度良好,12 次结果的RSD分别是:d(0.1)为 1.5%,d(0.5)为 1.8%,d(0.9)为 1.4%,D(4,3)为 0.9%.结论 该方法可靠、准确,可用于兰索拉唑原料药粒度及粒度分布的测定.
Abstract
Objective To establish a method for determination of particle size and particle size distribution of lansoprazole raw materials.Methods Light scattering method was used the particle refractive index was 1.57,the particle absorptivity was 0.1,the vibratory injection rate was 60%,the dispersion pressure was 3.0 Bar,the opacity was 0.5%～6%.Results The method has good repeatability,the RSD was 2.0%for d(0.1),2.1%for d(0.5),0.7%for D(0.9),0.7%for D(4,3).The middle precision is good.The RSD was 1.5%for d(0.1),1.8%for d(0.5),1.4%in d(0.9)and 0.9%in D(4,3).Conclusion The method is reliable and accurate,and can be used for the determination of particle size and particle size distribution of lansoprazole raw materials.
关键词
光散射法/兰索拉唑/粒度/粒度分布Key words
Light scattering/Lansoprazole/Particle size/Particle size distribution引用本文复制引用
出版年
2024
NETL
NSTL
万方数据