格列齐特中对甲苯磺酰胺含量的测定

Determination of p-Toluenesulfonamide Content in Gliclazide

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。

Abstract: 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.