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（ pH 3.0），流动相B为乙腈，检测波长为210 nm，柱温40℃，流速1.0 mL·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（0.0039μg·mL-1），最低检出限为0.013 ng（0.0013μg·mL-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-1 potassium dihydrogen phosphate(pH 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 was 1. 0 mL·min-1. Results CZYS -201402 -04 could be effectively separated with impurities. The LOQ was 0. 039 ng (0. 003 9 μg·mL-1 )and LOD was 0. 013 ng(0. 001 3μg·mL-1). RSD of repeatability was 1. 4% and RSD of interme-diate 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.
展开▼
