反相离子对色谱法测定羧甲司坦的含量及有关物质  

Determination of the Content and the Related Substances of Carbocisteine by Reversed ION-PAIR phase HPLC

作　　者：赵雪梅[1] 黄秀明[2] 

机构地区：[1]广州市药品检验所 [2]广东药学院,广州510160

出　　处：《中国药品标准》2007年第2期60-63,共4页Drug Standards of China

摘　　要：目的:采用反相离子对液相色谱法测定羧甲司坦的含量及有关物质。方法:色谱柱为Hypersil BDS柱(250mm×4.6mm,5μm)以(0.125g庚烷磺酸钠,0.25g磷酸氢二钾加水250mL溶解)-0.2%二氟乙酸-乙腈(30:68:2)为流动相,流速1.0mL·min-1,检测波长为215nm,柱温35℃。结果:羧甲司坦在25μg～200μg·mL-1浓度范围内,线性关系良好,r=0.9999,最低检测限为1.0ng;半胱氨酸在0.4～2.5μg·mL-1浓度范围内,线性关系良好,r=0.9999,最低检测限为1.2ng。结论:本方法简便、快速,结果准确、可靠,重现性好,可用于羧甲司坦的有关物质检查和含量测定。Objective：A reversed ion-pair phase HPLC method has been studied to determine the content and related substances of Carbocisteine. Methods ：Hypersil BDS C18 column （250mm × 4.6mm, 5um） ;Column temperature at 35 ℃ and the mobile phase： （0. 125g sodium heptanesulfonate and 0. 25g K2HPO4 ,dissolved in 250ml water）-0. 2% trifluoroacetic acid-acetonitrile （30 ： 68 ： 2） were used,detection was done at 215nm. Results ： The calibration curves were linear in the range of 25 200ug · mL^-1 for carbocistenine,0. 4-2.5ug · mL^-1 for cysteine. The limit detection of carbocisteine and cysteine were 1.0ng and 1.2ng ,respectively. Conclusion：This method is simple,quick and accurate with good repeatability,and suitable for the determination of the content and the related substances of carbocisteine.

关 键 词：羧甲司坦 含量测定 有关物质 反相离子对高效液相色谱法 

分 类 号：R988.1[医药卫生—药品]