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

DOI: 10.12677/AAC.2012.23005, PP. 25-28

Keywords: 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

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Abstract:

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.

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