缬沙坦原料药粒度的激光散射法测定

Determination of Valsartan Particle Size by Laser Light Scattering Method

建立了激光散射法测定缬沙坦原料药的粒度分布。采用Malvern Mastersizer 2000型激光粒度分析仪,HYDRO2000MU型湿法进样器,样品采用2%十二烷基硫酸钠分散,样品折射率1.53,样品吸收率0.01,遮光比8%~20%,超声30 s,泵速1 800 r/min,样品测量5次。结果 d(0.5)值的RSD均小于3%,d(0.1)和d(0.9)值的RSD均小于5%。本法可准确测定缬沙坦原料药的粒度。

A laser light scattering method was established for the determination of particle size distribution of valsartan. A Malvern Mastersizer 2000 type laser size analyzer and a HYDRO 2000MU type wet auto sampler were used. 2 % SDS was used as the dispersion agent. The determination conditions were determined as sample refractive index of 1.53, sample absorbency of 0.01, shading degree of 8%-20%, ultrasonic treatment for 30 s, pump speed of 1 800 r/min, and measurement for 5 times. The RSDs for d （0.5） values was lower than 3 %, and for d（0.1） and d（0.9） values were lower than 5%. Valsartan is almost insoluble in water, the particle size directly affects the dissolution rate of the preparation. This method is suitable for the determination of the particle size distribution of valsartan.