HPLC法测定抗丙肝新药CZYS-201402-04的有关物质  

Determination of related substances of a novel anti-HCV drug CZYS-201402-04 by HPLC

作　　者：陶鑫[1] 焦丹丹 吴卫忠[3] 张建军[4] 余洛汀[1] 

机构地区：[1]四川大学生物治疗国家重点实验室,四川成都610041 [2]常州寅盛药业有限公司,江苏常州213033 [3]常州大学,江苏常州213164 [4]中国药科大学,江苏南京210009

出　　处：《药学研究》2015年第5期266-268,271,共4页Journal of Pharmaceutical Research

基　　金："十二五"新药创制科技重大专项(No.2012ZX09103101079);江苏省科技支撑计划-社会发展项目(No.BE2014626)

摘　　要：目的采用高效液相色谱法测定新型丙型肝炎治疗药物CZYS-201402-04的有关物质。方法采用Zorbax Eclipse Plus C18(4.6 mm×100 mm,3.5μm),用二元梯度洗脱的方式,流动相A为10 mmol·L-1磷酸二氢钾溶液(p H 3.0),流动相B为乙腈,检测波长为210 nm,柱温40℃,流速1.0 m L·min-1。结果 CZYS-201402-04的峰能与相邻杂质峰完全分离。CZYS-201402-04定量限为0.039 ng(0.003 9μg·m L-1),最低检出限为0.013 ng(0.001 3μg·m L-1)。重复性RSD=1.5%(n=6),中间精密度RSD=1.4%(n=9)。样品溶液在24 h内稳定。结论该方法为CZYS-201402-04的有关物质检查提供了方便、灵活、精确、可靠的方法。Objective To establish an HPLC method for the determination of related substances of a novel anti- HCV drug CZYS- 201402- 04. Methods Zorbax Eclipse Plus C18（ 4. 6 mm × 100 mm,3. 5 μm） column was used. The mobile phase A was water solution containing 10 mmol·L- 1potassium dihydrogen phosphate（ p H 3. 0） and the mobile phase B was acetonitrile. The UV detection wavelength was 210 nm,the column temperature was 40 ℃ and the flow rate was1. 0 m L·min- 1. Results CZYS- 201402- 04 could be effectively separated with impurities. The LOQ was 0. 039 ng（ 0. 003 9 μg·m L- 1） and LOD was 0. 013 ng（ 0. 001 3 μg·m L- 1）. RSD of repeatability was 1. 4% and RSD of intermediate precision was 1. 5%. The solution was stable in 24 h. Conclusion The method was convenient,sensitive,accurate and reliable for the determination of assay and related substances of CZYS- 201402- 04.

关 键 词：高效液相色谱法 CZYS-201402-04 有关物质 

分 类 号：R927.1[医药卫生—药学]