【摘要】 采用液相色谱法对恩替卡韦口服制剂的有关物质进行了分离测定,色谱柱为Thermo C18柱(2.1 mm×150 mm,2μm),流动相为甲醇-0.2%甲酸水溶液(75∶25),流速0.3 mL/min,检测波长254 nm,柱温为30℃。在上述色谱条件下,测定了不同厂家恩替卡韦口服制剂中有关物质的含量。并采用液相色谱-质谱法分析了有关物质的化学结构信息,鉴定了2个主要有关物质的结构,均为恩替卡韦异构体。该研究为恩替卡韦口服制剂的质量控制和稳定性研究提供了重要依据。更多还原

【Abstract】 The related substances in Entecavir Oral Preparation were separated on a Thermo C18column(150 mm × 2.1 mm × 2 μm) by gradient elution,with methanol-0.2% formic acid as mobile phase at a flow rate of 0.3 mL/min and a column temperature of 30 ℃,and the detection wavelength was set at 254 nm.The proposed method was used to detect the related substances in Entecavir Oral Preparations from different pharmaceutical manufacturers.The chemical structures of related substances were analyzed by LC-MS/MS.Two structures of the related primary substances were identified,which both belonged to the isomers of entecavir.This study provided an important basis for the quality and stability control of this product.更多还原