激光散射法测定普伐他汀钠原料药粒度分布

Measurement of Particle Size Distribution of Pravastatin Sodium by Laser Light Scattering Method

目的建立普伐他汀钠原料药粒度分布的测定方法。方法采用激光粒度分析仪;湿法进样系统;样品折射率：1.554,分散介质：液体石蜡,分散介质折射率：1.468,测量次数：5次;样品与背景测量时间：5 s,遮光度：8%-20%。结果方法精密度测试中的d（0.1）、d（0.5）、d（0.9）的RSD均不大于5%,符合中国药典相关要求。结论该方法经验证,可用于普伐他汀钠原料药粒度分布的测定。

OBJECTIVE To establish a laser light scattering method for the determination of particle size distribution for Pravastatin sodium. METHODS Laser particle size analyzer was used with wet sample feeding system,sample RI 1. 554. Liquid paraffin RI 1.468 was used as dispersion medium. Measurement duration for both background and sample was 5 s. Measured for 5 times.Shading ratio was 8%-20%. RESULTS RSD of d（ 0.1）,d（ 0.5） and d（ 0.9） were no more than 5% in the percision test,and were all meet the requirements of China Pharmacopeia. CONCLUSION The method is suitable for the particle size distribution measurement for Pravastatin sodium base on the validation.