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Determination of related substances in Mannitol and Mannitol Injection by HPLC method
Author(s): LIU Jie, ZHOU Lingling, WANG Sheng, XIAO Fang, MA Yingying, REN Chuanjie
Pages: 580-
582,608
Year: 2018
Issue:
10
Journal: Qilu Pharmaceutical Affairs
Keyword: 甘露醇; 注射液; 有关物质; 高效液相色谱法;
Abstract: 目的 建立高效液相色谱法测定甘露醇及甘露醇注射液的有关物质.方法 采用强阳离子钙型交换柱(300 mm×8 mm),水为流动相,流速为0.5 mL?min-1,柱温为80℃,检测温度为55℃.结果 甘露醇及各杂质在相应的浓度范围内,峰面积与浓度均呈良好的线性关系,相关系数均大于0.999.结论 建立的方法快速、灵敏、准确,适用于甘露醇及甘露醇注射液中的有关物质测定.
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