Determination of Residual Organic Solvents in Fenticonazole Nitrate by Headspace Gas Chromatography
- VernacularTitle:顶空气相色谱法测定硝酸芬替康唑原料药中有机溶剂残留量
- Author:
Weizhi LIU
;
Hankun HU
;
Wei LIU
;
Mi ZHANG
;
Baogen ZHENG
;
Anni LIU
;
Qiang YAN
;
Lijuan ZHOU
;
Yiming LIU
- Publication Type:Journal Article
- Keywords:
GC;
Fenticonazole nitrate;
Residual organic solvent
- From:
China Pharmacist
2015;(1):18-19,20
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a method for the determination of dichloromethane, methanol and ethanol in fenticonazole ni-trate. Methods:The samples were detected by headspace GC. The column was OV-1301(30 m × 0. 53 mm,3. 0 μm), the detector was FID with nitrogen as the carrier gas, the detector temperature was 250 ℃ and the injector temperature was 200 ℃. Results:The linear range of dichloromethane, methanol and ethanol was 2. 436-21. 924(r=0. 998 8), 12. 268-110. 412(r=0. 999 5) and 20. 052-180. 468 μg·ml-1(r=0. 996 9) with the average recovery of 99. 30% (RSD=2. 36%), 100. 21%(RSD=1. 07%) and 100. 15%(RSD=1. 21%)(n=9), respectively. Conclusion:The detection method is sensitive, accurate and reliable, and can be used in the quality control of fenticonazole nitrate.
