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HPLC法测定注射用氧化型谷胱甘肽二钠有关物质及含量
引用本文:沈小钟,焦豪妍,王玉生,严振,张现涛. HPLC法测定注射用氧化型谷胱甘肽二钠有关物质及含量[J]. 山西临床医药, 2009, 0(24): 572-575
作者姓名:沈小钟  焦豪妍  王玉生  严振  张现涛
作者单位:广东省中药研究所药物研发中心
摘    要:目的:考察不同色谱条件下注射用氧化型谷胱甘肽二钠有关物质的色谱行为,建立注射用氧化型谷胱甘肽二钠有关物质高效液相色谱分析方法及含量测定方法。方法:固定相为ZorbaxXB-C18(4.6mm×250mm,5μm);流动相为0.006M辛烷磺酸钠溶液-甲醇(95:5);检测波长为210nm,柱温30℃。结果:注射用氧化型谷胱甘肽二钠的线性范围为0.5-10μg,r=0.9999,总有关物质含量小于1%。结论:此法简单,分离度良好,结果准确,可以用于注射用氧化型谷胱甘肽二钠的含量测定和有关物质的检测。

关 键 词:注射用氧化型谷胱甘肽二钠  高效液相色谱法

Determination of Oxidized Glutathione disodium salt for injection and its related substances by HPLC
Shen Xiaozhong,Jiao Haoyang,Wang Yusheng,Yan Zheng,Zhang Xiantao. Determination of Oxidized Glutathione disodium salt for injection and its related substances by HPLC[J]. Shanxi Clinical Medicine, 2009, 0(24): 572-575
Authors:Shen Xiaozhong  Jiao Haoyang  Wang Yusheng  Yan Zheng  Zhang Xiantao
Affiliation:* (Guangdong Research Institute of Traditional Chinese Medicine,Guangzhou, Guangdong,510520)
Abstract:Objective: To establish a determination of Oxidized Glutathione disodium salt for injection and its related substances by HPLC. Methods:HPLC analysis was carried out on ZorbaxXB-C18 (4.6 mm×250 mm,5 μm) with 0.006M 1-Octanesulfonic acid sodium salt : methyl alcohol(95:5) as mobile phase. The detection wavelength was 210 nm. Results: The method was linear in the range of 0.5 μg-10 μg, r=0.9999, the related substances of the peak area of oxidized glutathione disodium salt is no more than 1.2%. Conclusion This method was simple, reliable, accurate and highly sensitive. It may be ued for the determination of Oxidized Glutathione disodium salt and its related substances.
Keywords:Oxidized Glutathione disodium salt  HPLC
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