Simultaneous determination of seven residual solvents in clopidogrel bisulfate by headspace gas chromatography
10.19778/j.chp.2024.04.011
- VernacularTitle:顶空气相色谱法测定硫酸氢氯吡格雷中7种残留溶剂
- Author:
Lu CHEN
1
;
Xue GENG
;
Qiujie LIN
;
Shanying CAI
;
Zanmin CHEN
Author Information
1. 海南省检验检测研究院,海口 570216
- Keywords:
gas chromatography;
headspace sampling;
clopidogrel bisulfate;
organic solvent;
residual content;
programmed temperature
- From:
Drug Standards of China
2024;25(4):387-391
- CountryChina
- Language:Chinese
-
Abstract:
Objective:A gas chromatography(GC)method was established for the simultaneous determination of seven residual solvents in clopidogrel bisulfate,including methanol,acetone,isopropanol,dichloromethane,n-hexane,tetrahydrofuran and methylbenzene.Methods:The analysis was performed on an Agilent DB-1 capillary column(30 m ×0.32 mm,3.0 μm)under the programmed temperature.The carrier gas was high purity nitrogen,and the flow rate was 4.0 mL·min-1 with constant flow control.The detector was a hydrogen flame ionization detector(FID).The inlet temperature was 200 ℃,the detector temperature was 270 ℃ and the split ratio was 5∶1.The temperature of headspace injector was 85 ℃,and the equilibrium time was 20 min.Results:Seven residual solvents were separated completely.The linear relationship between peak area and the concentration range of seven residual solvents were good enough(r＞0.9993).The results of specificity,precision and recovery met the requirements.Conclusion:This method can be used for the determination of residual organic solvents in clopidogrel bisulfate.
