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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。
The laser scattering method was established to determine the particle size distribution of valsartan. Using Malvern Mastersizer 2000 laser particle size analyzer, HYDRO2000MU wet sampler, the sample was dispersed with 2% sodium dodecyl sulfate, the sample refractive index of 1.53, the sample absorbance of 0.01, shading ratio of 8% to 20%, ultrasound 30 s, pump speed 1 800 r / min, sample measurement 5 times. Results The RSDs of d (0.5) values were all less than 3%. The RSDs of d (0.1) and d (0.9) values were less than 5%. This method can accurately determine the particle size of valsartan API.