大黄酸-L-精氨酸共晶的纯化及近红外光谱法含量测定

Near Infrared Spectroscopy Used in Purification and Determination of Pharmaceutical Cocrystal

实验采用溶剂重结晶法对大黄酸-L-精氨酸共晶进行了纯化,得到了该共晶的标准品;利用二氯甲烷这一选择性溶剂及紫外分光光度法,估算出了共晶标准品的纯度>99.85%,并建立了相关标准曲线;对41个批次的共晶样品进行近红外光谱扫描,用偏最小二乘法建立了含量测定模型,相关系数高于0.998,并对建立的模型进行验证,从而建立了一种简便、快速、无损的共晶含量测定方法。

Standard Rhein-L-Arginine cocrystal was gotten used solution recrystallization after purification. Dichloromethane, chosen as a selective solution, was used to evaluate the purity of higher than 99.85% together with ultraviolet spectrophotometry. Standard cocrystal, curve of which was uhraviolet spectrophotometry was built for the determination as well. NIR spectrum of 41 batches of cocrystal was gotten. Partial least square method was used to build the determination model, whose correlation coefficient was higher than 0. 998, and the model was identified. Based on the above results, a simple, quick and lossless method was developed to determine the concentration of concentration of cocrystal.