HPLC法测定格列齐特缓释片的含量及有关物质

目的：建立一种适用于格列齐特缓释片有关物质及含量测定的HPLC分析方法。方法：采用Merck RP8（250mm×4.6mm,5μm）色谱柱,柱温30℃,以乙睛-水-三乙胺-三氟乙酸（45：55：0.1：0.1）为流动相,流速1.0mL/min,检测波长235nm。结果：格列齐特主峰与有关物质及降解产物均能达到有效分离。格列齐特在5.150～41.20μg/mL浓度范围内呈良好线性（r=0.9999）,检测限为0.013ng,含量测定的回收率为99.28%（n=9,RSD=1.21%）。结论：本法专属性强,结果准确可靠。

Determination of the gliclazide and related substances contents in gliclazide sustained release tablets using HPLC method

Objective：To establish an HPLC method to determine the gliclazide and related substances contents in gliclazide sustained release tablets.Methods：Merck RP8（250 mm×4.6 mm,5 μm） column was used.The column temperature was maintained at 30℃.Acetonitrile-water-triethyl-trifluoracetic acid（45：55：0.1：0.1） was used as mobile phase.The flow rate was set at 1.0 mL/min.The detection wavelength was 235 nm.Results：The peak of gliclazide was effectively separated from those of its related substances and degraded products.The concentration of gliclazide showed a good linear relationship in the range of 5.150 to 41.20 μg/mL（r=0.999 9）.The detection limit was 0.013 ng.The recovery rate was 99.28%（n=9,RSD=1.21%）.Conclusion：The method is specific,simple and reliable.