厄贝沙坦多晶型X-射线粉末衍射定量分析

Quantitative Determination of Irbesartan Polymorphs by X-ray Powder Diffraction

目的建立厄贝沙坦晶型原料药的晶型含量分析方法,为药品晶型质量控制提供技术支撑。方法采用X-射线粉末衍射法表征厄贝沙坦晶型A和晶型B。分别选取晶型A的特征衍射峰2θ=4.65°和晶型B的特征衍射峰2θ=7.99°的峰面积比值为定量参数,建立标准曲线检测晶型B的含量。结果晶型B在晶型A和晶型B混合物中含量为2%~50%(质量分数)内线性关系良好(r=0.9995),方法仪器精密度为4.7%,检测限浓度为1.12%(S/N=4.4)。结论本研究建立的方法准确方便,可用于厄贝沙坦原料晶型A和晶型B混合物中晶型B的定量分析。

OBJECTIVE To establish a method for the determination of the contents of irbesartan polymorphs and to provide technical support for the quality control of crystal forms. METHODS X-ray powder diffraction method was used to characterize form A and B of irbesartan. A standard curve method was developed by using the characteristic peak ratio of form A at 4.65° 2θ and form B at 7.99° 2θ as the quantitative parameters, and the content of form B was calculated by the standard curve. RESULTS The curve of form B in the mixtures of form A and B was linear over the range of 2%-50% with r of 0.999 5, the instrument precision was 4.7%, and the concentration of LOD was 1.12%(S/N=4.4). CONCLUSION The established method is accurate, simple, and can be used to determine the contents of form B in the mixtures of form A and B.