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高效液相色谱法测定右旋雷贝拉唑钠的对映体纯度

吉丹丹, 张玲, 谭淑珍, 薛琳

吉丹丹, 张玲, 谭淑珍, 薛琳. 高效液相色谱法测定右旋雷贝拉唑钠的对映体纯度[J]. 理化检验-化学分册, 2015, 51(7): 1010-1013. DOI: 10.11973/lhjy-hx201507030
引用本文: 吉丹丹, 张玲, 谭淑珍, 薛琳. 高效液相色谱法测定右旋雷贝拉唑钠的对映体纯度[J]. 理化检验-化学分册, 2015, 51(7): 1010-1013. DOI: 10.11973/lhjy-hx201507030
JI Dan-dan, ZHANG Ling, TAN Shu-zhen, XUE Lin. Determination of Enantiomeric Purity of R-Rabeprazole Sodium by HPLC[J]. PHYSICAL TESTING AND CHEMICAL ANALYSIS PART B:CHEMICAL ANALYSIS, 2015, 51(7): 1010-1013. DOI: 10.11973/lhjy-hx201507030
Citation: JI Dan-dan, ZHANG Ling, TAN Shu-zhen, XUE Lin. Determination of Enantiomeric Purity of R-Rabeprazole Sodium by HPLC[J]. PHYSICAL TESTING AND CHEMICAL ANALYSIS PART B:CHEMICAL ANALYSIS, 2015, 51(7): 1010-1013. DOI: 10.11973/lhjy-hx201507030

高效液相色谱法测定右旋雷贝拉唑钠的对映体纯度

详细信息
    作者简介:

    吉丹丹(1991-),女,湖南长沙人,硕士研究生,主要研究方向为药物合成及分析.

  • 中图分类号: O657.7

Determination of Enantiomeric Purity of R-Rabeprazole Sodium by HPLC

  • 摘要: 采用高效液相色谱法测定右旋雷贝拉唑钠对映体的纯度.以α1-酸性糖蛋白键合硅胶为填充剂的CHIRALPAK-AGP手性柱为固定相,用乙腈-pH 6.0磷酸盐(1+9)混合溶液为流动相进行洗脱,用紫外检测器进行测定,检测波长为285 nm.左旋雷贝拉唑钠的质量浓度在38.4~576 μg·L-1范围内与其峰面积呈线性关系,检出限(3S/N)为0.2 ng,测定下限(10S/N)为0.56 ng.加标回收率在91.1%~102%之间,测定值的相对标准偏差在2.4%~4.3%之间.
    Abstract: A HPLC method was developed for the determination of enantiomeric purity of R-rabeprazole sodium. A chiral column (CHIRALPAK-AGP) packed with α1-acid glycoprotein immobilized on silica gel was used as the stationary phase,with a mixed solution of acetonitrile and phosphate buffer (pH 6.0) as the mobile phase for elution. UV detection at the wavelength of 285 nm was utilized. Linear relationship between the peak area and the mass concentration of S-rabeprazole sodium were found in the range of 38.4-576 μg·L-1 with detection limit (3S/N) of 0.2 ng and the lower limit of determination (10S/N) of 0.56 ng. The recovery rates measured by standard addition method were in the range of 91.1%-102%,and RSD were in the range of 2.4%-4.3%.
  • [1] Shan Ren,Mi-Jin P,HONGKEE S,et al. Effect of pharmaceutical excipients on aqueous stability of rabeprazole sodium[J]. International Journal of Pharmaceutics,2008,305(1/2):197-204.
    [2] GARCIA C V,PAIM C S,STEPPE M,et al. Development and validation of a dissolution test for rabeprazole sodium in coated tablets[J]. Journal of Pharmaceutical and Biomedical Analysis,2006,41(3):833-837.
    [3] MIURA M,TADA H,SRTOH S. Determination of rabeprazole enantiomers and their metabolites by high-performance liquid chromatography with solid-phase extraction[J]. Journal of Pharmaceutical and Biomedical Analysis,2006,41(2):565-570.
    [4] RAO R N,RAJU A N,NAGARAJU D. Enantiospecific resolution of rabeprazole by liquid chromatography on amylose-derived chiral stationary phase using photo diode array and polarimetric detectors in series[J]. Talanta,2006,74(4):805-810.
    [5] RAM P,GHANTA M R,MADHUSUDAN R G,et al. An improved process for the production of rabeprazole sodium substantially free from the impurities[J]. Organic Process Research and Development,2009,13(5):896-899.
    [6] 陈敖,王智慧.雷贝拉唑的合成[J].精细与专用化学品,2010,18(2):28-29.
    [7] 邱飞,刁勇.雷贝拉唑钠的合成[J].中国医药工业杂志,2010,41(1):9-10.
    [8] 鲁亚洲,牛犇,陈严波.质子泵抑制剂雷贝拉唑钠的合成[J].化工时刊,2011,25(8):46-48.
    [9] USHIKU S S,NIIHARI N U,TORIDE S M,et al. Pyridine derives having anti-ulcerative activity: US,5045552[P]. 1991-09-03.
    [10] LARSSON E,STENHEDE U J,SORENSEN H,et al. Process for synthesis of substituted sulphoxides: WO,9602535A1[P]. 1996-02-01.
    [11] 徐宝财,王关兴,周雅文.高对映体选择性制备(S)-雷贝拉唑的方法:中国,101157686A[P]. 2008-04-09.
    [12] 徐宝财.雷贝拉唑钠对映体的不对称合成[D].北京:北京工商大学,2008.
    [13] 金薇,杨永健,彭兴盛,等.雷贝拉唑钠对映体在α1-酸性糖蛋白柱上的手性拆分[J].药物分析杂志,2006,26(2):1715-1717.
    [14] JX20080210国家食品药品监督管理局进口药品注册标准 埃索美拉唑钠[S].
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出版历程
  • 收稿日期:  2014-07-20
  • 刊出日期:  2015-07-17

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