激光散射法测定右美托咪定的粒度分布

Measurement of Particle Size Distribution of Dexmedetomidine by Laser Light Scattering Method

目的建立检测右美托咪定原料药粒度分布的方法。方法使用激光粒度分析仪,采用干法检测右美托咪定原料药的粒径。经优化,折射率设为1.56,漏斗池高度设为1.5 mm,遮光度设为3.0%~4.0%,分散气体的压力设为0.8 bar,进样速度设为50%,样品测量时间设为18 s。结果在优化条件下,粒径分布结果的RSD值小于2.0%,数据与电子显微镜扫描结果相似。结论方法操作简单,重现性较好、准确度较高,可用于右美托咪定原料药的粒度测定。

Objective To establish a method for the detection of particle size distribution of dexmedetomidine bulk drug.Methods Using laser particle size analyzer,the particle size of dexmedetomidine bulk drug was detected by dry method.After optimization,the refractive index was set at 1.56,the height of funnel pool was set at 1.5 mm,the shading degree was set at 3.0%-4.0%,the pressure of dispersed gas was set at 0.8 bar,the injection speed was set at 50%,and the sample measurement time was set at 18 s.Results Under the optimized conditions,the RSDs of the results of particle size distribution were less than 2.0%,and the detected data were similar to the scanning results of electron microscope.Conclusion The method is simple,reproducible and accurate,and can be used for the determination of particle size of dexmedetomidine bulk drug.