Determination of 4-Hydrazinobenzenesulfonamide Hydrochloride in Celecoxib by HPLC
- VernacularTitle:HPLC法测定塞来昔布中对磺酰胺基苯肼盐酸盐的含量
- Author:
Xiulan XU
- Keywords:
Celecoxib;
4-Hydrazinobenzenesulfonamide hydrochloride;
Genotoxic impurity;
HPLC
- From:
China Pharmacist
2017;20(2):360-362
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a method for the determination of 4-hydrazinobenzenesulfonamide hydrochloride in celecoxib. Methods:HPLC was used and the chromatographic column was a Hypercarb series C18 column (150 mm × 4. 6 mm, 3 μm) with 100% porous graphite as the filler. The mobile phase consisted of 10 mmol·L-1 ammonium acetate aqueous solution-methanol (50 :50) and methanol. The flow rate was 0. 8 ml·min-1 and the detection wavelength was 220 nm. The column temperature was 35 ℃and the injection volume was 20 μl. Results:The linear range was 99. 897-599. 382 ng·ml-1(r=0. 9982) for 4-hydrazinobenzene-sulfonamide hydrochloride. The average recovery was 97. 4%(RSD=3. 0%,n=9). Conclusion:The method is simple and accurate, and can be used for the determination of 4-hydrazinobenzenesulfonamide hydrochloride in celecoxib.
