摘要
目的:研究用于痛风治疗的新型高选择性尿酸转运体1(URAT1)抑制剂HR011303原料药的有关物质。方法:采用Agilent Eclipse Plus-XDB C18(100 mm×4.6 mm,3.5μm)色谱柱,以0.02 mol·L^-1磷酸二氢钠溶液(含0.1%三乙胺,磷酸调节pH 2.70)和乙腈为流动相,梯度洗脱,流速1.0 mL·min^-1,紫外检测波长230 nm。结果:HR011303与各有关物质的色谱峰能够完全分离,HR011303及杂质A、B、C的定量下限为0.39~1.00 ng,检测下限为0.12~0.30 ng;有关物质(杂质A、杂质B及杂质C)的主要来源为工艺和降解杂质。结论:该方法可用于HR011303原料药的质量控制。有关物质的含量可以采用加校正因子的自身对照法计算。
Objective:To study the related substances of HR011303,a novel high selective urate transporter 1(URAT 1)inhibitor used for gout theament.Methods:The separation was carried out with Agilent Eclipse Plus-XDB C18 column(100 mm×4.6 mm,3.5μm)by gradient elution method,using a mixture of 0.02 mol·L^-1 sodium dihydrogen phosphate solution(containing 0.1% triethylamine,adjusted pH to 2.70 with phosphate acid)and acetonitrile as the mobile phase at a flow rate of 1.0 mL·min^-1,and the UV detection wavelength was set at 230 nm.Results:The peaks of HR011303 and related compounds can be separated completely.The lowest detection limits of HR011303 and impurities A,B,C was 0.12-0.30 ng,and the lowest quantification limits was 0.39-1.00 ng.The main sources of related substances(impurity A,impurity B,impurity C)are process and degradation impurities.Conclusion:The established method can be used for the quality control of HR011303,and impurities content can be calculated by using self-reference method with correction factors.
作者
王菊
宋洁琼
尹玉祥
姚伟
凡迪
邱振均
杭太俊
WANG Ju;SONG Jie-qiong;YIN Yu-xiang;YAO Wei;FAN Di;QIU Zhen-jun;HANG Tai-jun(China Pharmaceutical University,Nanjing 210009,China;Jiangsu Hengrui Medicine Co.,Ltd,Lianyungang 222047,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2020年第4期664-671,共8页
Chinese Journal of Pharmaceutical Analysis
