Determination of related substances of a novel anti-HCV drug CZYS-201402-04 by HPLC
TAO Xin
JIAO Dan-dan
WU Wei-zhong
ZHANG Jian-jun
YU Luo-ting
Abstract：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.
Keywords：HPLCCZYS-201402-04Related substances
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 266-268,271 )