左旋泮托拉唑钠肠溶片中有关物质的HPLC法测定  

Determination of Related Substances in(S)-Pantoprazole Sodium Enteric-coated Tablets by HPLC

作　　者：沈卫阳[1] 窦晓睿[1] 陈灵芳[1] 沈圃毅 施睿[2] 

机构地区：[1]中国药科大学理学院,药物质量与安全预警教育部重点实验室,江苏南京210009 [2]南京师范大学附属中学,江苏南京210003

出　　处：《中国医药工业杂志》2015年第4期391-395,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了高效液相色谱法测定左旋泮托拉唑钠（1）肠溶片中的有关物质A、B、C、D＆F和E。采用C18色谱柱,以铵盐缓冲液（四丁基硫酸氢铵1.1 g,乙酸铵3.85 g,用水溶解并稀释至1 L,以氨水调至p H 7.9）∶乙腈（65∶35）为流动相,检测波长290 nm。1与各杂质及强制降解破坏产物均能完全分离。有关物质A、B、C、D＆F和E分别在0.080~2.400、0.050~1.500、0.033~1.000、0.080~2.400和0.033~1.000μg/ml范围内线性关系良好;平均回收率分别为100.2%、101.6%、99.0%、100.2%和104.0%,RSD分别为1.5%、0.64%、3.0%、0.91%和1.1%。同时建立了手性固定相HPLC法测定右旋泮托拉唑钠（2）,可有效检测1肠溶片中的2。An HPLC method was established for the determination of related substances in（S）-pantoprazole sodium（1） enteric-coated tablets, including related substances A, B, C, DF and E. A C（18） column was used, with the mobile phase of ammonium buffer（ammonium acetate 3.85 g and tetrabutylammonium hydrogen sulfate 1.1 g in 1 L water, and adjusted to p H 7.9 by ammonium hydroxide）∶acetonitrile（65∶35）, at the detection wavelength of 290 nm. 1 was separated well from the above related substances and degradation products. The calibration curves for related substances A, B, C, DF and E were linear in the ranges of 0.080- 2.400, 0.050- 1.500, 0.033- 1.000, 0.080- 2.400 and 0.033- 1.000 μg/ml, respectively. Their average recoveries were 100.2%, 101.6%, 99.0%, 100.2% and 104.0%, with RSDs of 1.5%, 0.64%, 3.0%, 0.91% and 1.1%, respectively. In addition, an HPLC method using Chiralcel OJ-RH column was established for the effective determination of（R）-pantoprazole sodium（2） in 1 enteric-coated tablets.

关 键 词：泮托拉唑钠 肠溶片 有关物质 高效液相色谱 测定 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]