高效液相色谱法测定注射用右旋雷贝拉唑钠粉针剂含量  

Assay of dexrabeprazole sodium for injection by high performance liquid chromatography

作　　者：李蒲江 谭淑珍[1] 曾巨澜[1] 华坤鹏 冯雪[1] 

机构地区：[1]长沙理工大学化学与生物工程学院,湖南长沙410114

出　　处：《应用化工》2016年第2期373-376,共4页Applied Chemical Industry

基　　金：湖南省教育厅资助科研项目(14A012)

摘　　要：建立了一种测定注射用右旋雷贝拉唑钠粉针剂含量的高效液相色谱法,以YMC Triart C18柱（4.6 mm×250 mm,5μm）作为分离柱,以乙腈-pH 6.0磷酸盐缓冲溶液（40∶60,V/V）为流动相,流速1.0 mL/min,柱温25℃,检测波长285 nm。在此条件下,溶剂、辅料及各已知杂质对测定结果均无干扰。当采用外标法计算供试品中右旋雷贝拉唑钠浓度时,在0.02-0.08 mg/mL范围内右旋雷贝拉唑钠浓度与峰面积的线性关系良好,相关系数可达到0.999 9,在低、中、高3个浓度下的加标回收率平均值为100.8%。对于3批实际样品,采用该法测得含量分别为标示量的100.93%,101.31%,99.87%,含量均匀度均合格。A high performance liquid chromatography （HPLC） method has been developed for assay of dexraheprazole sodium for injection. A YMC triart C18 column （250 mm ×4.6 mm ,dp = 5 μm） is used. The mobile phase consists of acetonitrile and pH 6.0 phosphate buffer with a volume ratio of 40/60 at a flow rate of 1.0 mL/min, column temperature 25 ℃ and the detection wavelength was set at 285 nm. Under this condition, the solvent, auxiliary materials and every specified impurity don＇t interfere with the accuracy for assay of dexrabeprazole sodium. The external standard method is used to caculate the results. There is good linear relation between the peak area and concentration of dexrabeprazole sodium in the range of 0.02 - 0.08 mg/mL, the correlation coefficient is 0.999 9. The average recoveries measured by standard addition method at three different concentrations is 100.8%. By using this method, the contents of three practical samples to their labelled amounts are 100.93%, 101.31% and 99.87 %, respectively, and the results for the content uniformity meet the requirement.

关 键 词：右旋雷贝拉唑钠 粉针剂 含量测定 高效液相色谱法 

分 类 号：TQ460.7[化学工程—制药化工] R927.2[医药卫生—药学]