替莫唑胺原料药粒度测定方法研究

Study on Particle Size Test Method of Temozolomide

采用Malvern Mastersizer 2000型激光粒度分析仪研究微粉化替莫唑胺粒度测定方法。通过筛选分散剂种类、表面活性剂及其浓度,设定仪器参数,筛选样品浓度及进行溶液稳定性研究确定了一种全新的替莫唑胺粒度测定方法。方法的精密度和耐用性验证结果表明本文确定的方法精密度及耐用性好。本法可准确测定微粉化替莫唑胺原料药的粒度。

A new test method was studied for the determination of particle size of Temozolomide by using Malvern Mastersizer2000type laser size analyzer.The method was established by the screening of dispersion agent,surfactant and its concentration,setting the parameters of analyzer,screening of samples concentration,and studying of solution stability.The method was validated for precision and robustness.The method validation results showed that the test method established by this study is precise and robust.The test method can be used to test the particle size of micronized temozolomide accurately.