采用差示扫描量热法定量分析固体分散体中的依折麦布晶型

Quantitative Analysis of Ezetimibe Polymorph in Solid Dispersion by Differential Scanning Calorimetry

采用差示扫描量热法检测依折麦布(1)固体分散体中晶型药物的含量。通过在辅料中加入不同比例的晶型药物,制备不同含量晶型药物的固体分散体样品,建立其吸热峰焓值与晶型药物含量间的线性关系,并完成检测方法的验证,以实现1固体分散体中晶型药物含量的定量分析。结果显示,当1固体分散体中晶型药物含量为0.5%~10%时,其晶型含量与吸热峰焓值间的线性关系良好,且方法具有良好的精密度,可作为检测1固体分散体中无定形药物转化为晶型药物的定量分析方法,为1固体分散体的制备及质量评价提供了参考。

The content of ezetimibe(1)polymorph in solid dispersion was determined by differential scanning calorimetry.By adding different proportions of polymorph drug into the excipients,the sold dispersion samples with different contents of polymorph drug were prepared.The linear relationship between the enthalpy value of its endothermic peak and the content of polymorphs was established.The validation of the detection method was completed,and the quantitative analysis of the content of polymorph in solid dispersion was realized.The results showed that there was a good linearity between the content of polymorph and the enthalpy value of endothermic peak when the content range of polymorphs in 1 solid dispersion was 0.5%-10%.The established method has good precision,which can be used as a method for quantitative analysis of transforming amorphous drugs into polymorph drugs in 1 solid dispersion,and also provide a reference for the preparation and quality evaluation of 1 solid dispersion.