激光散射法测定妥布霉素地塞米松滴眼液及其原料药地塞米松的粒度分布

Determination of the particle size distribution of Tobramycin dexamethasone eye drops and its active pharmaceutical ingredient Dexamethasone by Laser scattering method

目的采用激光散射法测定妥布霉素地塞米松滴眼液及其原料药地塞米松的粒度及粒度分布。方法采用马尔文Mastersizer3000激光粒度仪,HydroEV型湿法进样器,以地塞米松饱和溶液为分散介质(折射率1.33),样品折射率1.59,吸收率0.001,背景测量时间10s,样品测量时间10s,遮光度5%~10%,泵转速2×10^(3)r·min^(-1),滴眼液直接加样平衡2min后测定;地塞米松以0.01%吐温20分散后加样,20%强度超声5min后再以2%强度超声5min测定。结果滴眼液及地塞米松的粒度分布测定值d(0.1)、d(0.5)、d(0.9)的RSD均小于5%,并与显微测定结果相符。结论所用激光散射法操作简便、重复性好,适用于测定妥布霉素地塞米松滴眼液及地塞米松原料药的粒度及粒度分布。

OBJECTIVE To determine the particle size Distribution of Tobramycin dexamethasone eye drops and dexamethasone by Laser scattering method.METHODS The Malvern Mastersizer 3000 laser particle size analyzer with Hydro EV wet sampler was used.The dispersion medium was Dexamethasone saturated solution with refractive index of 1.33,sample refractive index was 1.59,sample absorbency was 0.001,measuring time for background and sample was 10 s,laser obscuration was 5%-10%,and strring rate was 2×10^(3)r·min^(-1).The preparation was directly determined after 2 min of equilibration,the Dexamethasone active pharmaceutical ingredient(API)was prepared with 0.01%Tween 20,and was determined after 20%ultrasonicaction 5 min and 2%ultrasonicaction 5 min.RESULTS The relative standard deviation values(RSD)of d(0.1),d(0.5)and d(0.9)of the particle size distribution of the preparation and Dexamethasone were all less than 5%.The results were generally consistent with the microscopy method.CONCLUSION The method is sample,accurate and reproducible,which is suitable for the particle size control of Tobramycin dexamethasone eye drops and Dexamethasone API.