摘要
目的:建立塞来昔布中基因毒性杂质对磺酰胺基苯肼盐酸盐的含量测定方法。方法:采用HPLC法,色谱柱:以100%多孔渗水石墨为填料的Hypercarb系列C18柱(150 mm×4.6 mm,3μm);流动相:10 mmol·L^(-1)乙酸铵水溶液-甲醇(50∶50)和甲醇,梯度洗脱;流速:0.8 ml·min^(-1);检测波长:220 nm;柱温:35℃;进样量:20μl。结果:对磺酰胺基苯肼盐酸盐在99.897~599.382 ng·ml^(-1)(r=0.998 2)浓度范围内与峰面积呈良好的线性关系。平均回收率为97.4%(RSD=3.0%,n=9)。结论:该方法简便、准确,可用于塞来昔布中对磺酰胺基苯肼盐酸盐的含量测定。
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 Cls 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 = 0.998 2） 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.
作者
徐秀兰
Xu Xiulan(The Fourth Peopleg Hospital of Rudong County in Jiangsu Province, Jiangsu Nantong 226400, Chin)
出处
《中国药师》
CAS
2017年第2期360-362,共3页
China Pharmacist
