Determination of Three Stereoisomers in Baloxavir Marboxil by Reversed-phase HPLC
10.3870/j.issn.1004-0781.2025.04.021
- VernacularTitle:反相高效液相色谱法同时测定玛巴洛沙韦原料药中3种立体异构体含量
- Author:
Kai SHI
1
;
Kai YAN
;
Ting SUN
;
Xue FENG
;
Fugang ZHOU
;
Yuxia HE
;
Xueli LIU
;
Jialiang ZHU
Author Information
1. 石药集团中奇制药技术(石家庄)有限公司,石家庄 050035
- Publication Type:Journal Article
- Keywords:
Baloxavir marboxil;
Stereoisomer;
Content determination;
Reversed-phase high performance liquid chromatography
- From:
Herald of Medicine
2025;44(4):633-638
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a reversed-phase HPLC method for determining three stereoisomers in baloxavir marboxil and provide a basis for the quality specification of baloxavir marboxil.Methods The chromatographic column was CHIRALPAK IC-3(4.6 mm × 150 mm,3 μm),The mobile phase was acetonitrile-0.1％formic acid aqueous solution-isopropanol(35:50:15).The column temperature was 40 ℃.The flow rate was 0.5 mL·min-1.The injection volume was 10 μL.The detection wavelength was 259 nm.Result The isomer peaks were completely separated from the principal component peak.The detection limits for stereoisomers 1,2 and 3 were 0.024 7,0.038 7,0.038 1 μg·mL-1 respectively.The quantitation limits for stereoisomers 1,2 and 3 were 0.049 4,0.077 3,0.076 1 μg·mL-1 respectively.There were good linear relationships between the concentrations and peak area within the ranges of the study,and the linearity concentration ranges of stereoisomers 1,2 and 3 were 0.049 5-0.989 0 μg·mL-1,0.051 6-1.031 0 μg·mL-1,0.050 8-1.015 0 μg·mL-1 respectively.The linear correlation coefficients were 0.999 4.The recovery was 92.28％-103.90％.The sample solution was stable in 48 h at room temperature.Conclusion The method is accurate and reliable for determining stereoisomers in baloxavir marboxil,and provide a guideline of quality standards of baloxavir marboxil and safety evalution.
