Department of Chemical Research, Aurobindo Pharma Ltd. Research Centre, 313, Bachupally, Quthubullapur Mandal, Hyderabad 500090, India.
J Pharm Biomed Anal. 2010 Aug 1;52(4):620-4. doi: 10.1016/j.jpba.2010.01.034. Epub 2010 Jan 25.
Rabeprazole sodium [1] is a proton pump inhibitor, used as an antiulcerative. During the manufacturing of rabeprazole sodium, we observed an unknown impurity at levels 0.05-0.1% in HPLC analysis along with the known potential impurities. This new unknown impurity was isolated using preparative liquid chromatography. Based on the complete spectral analysis ((1)H NMR, (13)C NMR, DEPT, Mass and IR), this new impurity was designated as 2-[[(3-methyl-4-(methylthio)-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole (methylthio impurity of rabeprazole). Impurity isolation, structure elucidation and probable formation mechanism was discussed.
雷贝拉唑钠[1]是一种质子泵抑制剂，用作抗溃疡药。在雷贝拉唑钠的生产过程中，我们在 HPLC 分析中发现了一种未知杂质，其水平为 0.05-0.1%，同时还存在已知的潜在杂质。使用制备液相色谱法对这种新的未知杂质进行了分离。根据完整的光谱分析（（1）H NMR、（13）C NMR、DEPT、质谱和 IR），将这种新杂质指定为 2-[[(3-甲基-4-(甲硫基)-2-吡啶基)甲基]亚磺酰基]-1H-苯并咪唑（雷贝拉唑的甲硫基杂质）。讨论了杂质的分离、结构阐明和可能的形成机制。
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