高效液相法测定醋酸阿比特龙片有关物质含量  

Determination of Related Substances in Abiraterone Acetate Tablets by HPLC

作　　者：凌怀娟 贾志祥 叶丹 吴倩 宋林 LING Huijuan;JIA Zhixiang;YE Dan;WU Qian;SONG Lin(Jiangsu Lianhuan Pharmaceutical Co.,Ltd.,Yangzhou 225000,China)

机构地区：[1]江苏联环药业股份有限公司,江苏扬州225000

出　　处：《山东化工》2025年第2期204-206,共3页Shandong Chemical Industry

摘　　要：建立能测定醋酸阿比特龙片中有关物质的HPLC法。方法:设置高效液相检测条件以Agilent ZORBAXBonus-RPC_(18)为色谱柱,流动相A由甲醇和乙酸铵组成,流动相B由甲醇和乙腈组成,流速为1.0 mL/min进行洗脱,柱温20℃;检测波长为254 nm。结论:主成分与相邻杂质分离度良好,且空白溶剂和辅料没有微小倒峰干扰,不会干扰有关物质的测定。线性相关系数r为1.00,检出限与定量限均符合要求;重复性良好及精密度高,微调色谱条件后耐用性良好。因此,能够快速、有效、准确和可靠地分离检测出醋酸阿比特龙片的有关物质含量,有利于提高醋酸阿比特龙片的产品质量,提高患者用药安全性。Establish an HPLC method for the determination of related substances in abiraterone acetate tablets.Method:Set up HPLC detection conditions with Agilent ZORBAXBonus-RPC_(18) as the column,methanol and ammonium acetate as the mobile phase A,methanol and acetonitrile as the mobile phase B,flow rate of 1.0 mL/min for elution,and column temperature of 20℃;The detection wavelength is 254 nm.Conclusion:The separation degree between the main components and adjacent impurities is good,and there is no slight peak inversion interference from the blank solvent and excipients,which will not interfere with the determination of related substances.The linear correlation coefficients r is 1.00,and the LOD and LOQ meet the requirements;Good repeatability and high precision,with good robustness after fine-tuning chromatographic conditions.Therefore,the ability to quickly,effectively,accurately,and reliably separate and detect the content of related substances in abiraterone acetate tablets,is beneficial for improving the product quality and enhancing patient medication safety.

关 键 词：醋酸阿比特龙片 有关物质 HPLC 含量测定 

分 类 号：TQ460[化学工程—制药化工] R917[医药卫生—药物分析学]