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HPLC法测定乙酰谷酰胺葡萄糖注射液中乙酰谷酰胺的含量和有关物质
引用本文:邵仁华,袁卫. HPLC法测定乙酰谷酰胺葡萄糖注射液中乙酰谷酰胺的含量和有关物质[J]. 齐鲁药事, 2007, 26(6): 336-338
作者姓名:邵仁华  袁卫
作者单位:青岛国风集团金海制药有限责任公司,山东,青岛,266042
摘    要:
目的建立HPLC法测定乙酰谷酰胺葡萄糖注射液中乙酰谷酰胺的含量和有关物质。方法采用氨基柱,以0.05mol.L-1磷酸二氢钾溶液(用1mol.L-1氢氧化钾溶液调pH至5.0)-乙腈(30∶70)为流动相,检测波长215nm,流速1.0mL.min-1。结果乙酰谷酰胺在0.04~0.36mg.mL-1范围内呈良好的线性关系(r=0.9992),RSD=0.58%(n=6)。结论该法简便准确,可作为该药品乙酰谷酰胺含量和有关物质的测定方法。

关 键 词:高效液相色谱法  乙酰谷酰胺  含量测定  有关物质
文章编号:1672-7738(2007)06-0336-03

Determination of aceglutamide and related substances in Aceglutamide and Glucose Injection by HPLC
SHAO Ren-hua,YUAN Wei. Determination of aceglutamide and related substances in Aceglutamide and Glucose Injection by HPLC[J]. qilu pharmaceutical affairs, 2007, 26(6): 336-338
Authors:SHAO Ren-hua  YUAN Wei
Affiliation:Qingdao Growful Group Jinhai Pharmaceutical Share Limited Corporation, Qingdao, 266042
Abstract:
OBJECTIVE To establish an HPLC method for determination of Aceglutamide and related substances in Aceglutamide and Glucose Injection.METHODS NH2 column was used with the mobile phase of 0.05mol·L-1 potassium dihydrogen phosphate(adjust with 1mol·L-1 potassium hydroxide to pH 5.0)-acetonitrile(30∶70).Detection wavelength was 215nm and the flow rate was 1.0mL·min-1.RESULTS There was a very good linear relationship in the range of 0.04~0.36 mg·mL-1(r=0.9992),RSD=0.58%(n=6).CONCLUSION The method was convenient and accurate,suitable for determination of aceglutamide and related substances in Aceglutamide and Glucose Injection.
Keywords:HPLC   Aceglutamide   content determination   related substances
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