AAC  >> Vol. 2 No. 3 (August 2012)

    格列齐特中对甲苯磺酰胺含量的测定
    Determination of p-Toluenesulfonamide Content in Gliclazide

  • 全文下载: PDF(347KB) HTML   XML   PP.25-28   DOI: 10.12677/AAC.2012.23005  
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作者:  

魏乐坤:山东省医药工业研究所,济南

关键词:
高效液相色谱法格列齐特对甲苯磺酰胺High Performance Liquid Chromatography (HPLC); Gliclazide; p-Toluenesulfonamide

摘要:
目的:建立格列齐特中对甲苯磺酰胺含量的测定方法。方法:采用高效液相色谱法,色谱柱为Agilent ZORBAX Eclipse XDB C8柱,用外标法定量。结果:待测杂质对甲苯磺酰胺在0.4~1.2 μg/ml范围内线性关系良好(r = 0.9993),平均回收率(n = 9)为99.1%。结论:此方法简单、准确、灵敏度高,可用于格列齐特中对甲苯磺酰胺的杂质检查。

Objective: To establish a method for the determination of p-Toluenesulfonamide content in Gliclazide. Methods: Using High Performance Liquid Chromatography (HPLC) method with an Agilent ZORBAX Eclipse XDB C8 column. External standard method for quantitative. Results: The liner range of impurity p-Toluenesulfonamide was 0.4 - 1.2 g/ml, which showed good linearity (r = 0.9993). The average recovery was 99.1%. Conclusions: The method is simple, accurate and sensitive. It can be used for the determination of p-Toluenesulfonamide limit in Gliclazide.

文章引用:
魏乐坤. 格列齐特中对甲苯磺酰胺含量的测定[J]. 分析化学进展, 2012, 2(3): 25-28. http://dx.doi.org/10.12677/AAC.2012.23005