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

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。

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.