中国药房2011，Vol.22Issue(17)：1611-1613,3.
RP-HPLC法测定注射用甲磺酸加贝酯中有关物质的含量
Content Determination of Related Substances in Gabexate Mesylate for Injection by RP-HPLC
袁利杰 1杨本霞 1陈杰 1郑子栋1
作者信息
- 1. 河南省食品药品检验所,郑州市450003
- 折叠
摘要
Abstract
OBJECTIVE: To establish the method for the content determination of related substances in Gabexate mesylate for injection.METHODS: RP-HPLC method was adopted.The determination was performed on Agilent C18 column with mobile phase consisted of methanol-mixed buffer solution (pH 5.2)-isopropanol (382:152:8) at flow rate of 1.0 mL·min-1.The column temperature was set at 30 ℃.The detection wavelength of ethylparaben was set at 258 nm and the detection wavelength of other impurities was set at 236 nm.RESULTS: Related substances were completely separated from the main constituent.The linear range of ethylparaben was 0.014 9～9.90 μg·mL-1 (r=0.999 5) with average recovery of 99.4％ (RSD=0.5％).The contents of ethylparaben in 3 batches of samples were 0.22％, 0.21％ and 0.24％ and the contents of other related substances were 0.31％, 0.20％ and 0.24％,respectively.CONCLUSION: The method is sensitive and specific for the quality control of Gabexate mesylate for injection.关键词
注射用甲磺酸加贝酯/有关物质/羟苯乙酯/反相高效液相色谱法/含量测定分类
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袁利杰,杨本霞,陈杰,郑子栋..RP-HPLC法测定注射用甲磺酸加贝酯中有关物质的含量[J].中国药房,2011,22(17):1611-1613,3.
