HPLC法测定格列美脲胶囊中格列美脲的含量  

DETERMINATION OF GLIMEPIRIDE IN GLIMEPIRIDE CAPSULES BY HPLC

作　　者：杨蕾[1] 谢华[1] 黄瑛[1] 刘仲义[1] 

机构地区：[1]四川省药品检验所,成都610036

出　　处：《中国药品标准》2002年第6期58-59,共2页Drug Standards of China

摘　　要：目的:建立RP—HPLC法测定格列美脲胶囊中格列美脲的含量。方法:采用C_(18)柱,甲醇—磷酸二氢铵溶液(取磷酸二氢铵1.725g,加水300ml溶解,用磷酸调pH3.5±0.05)(8:3)为流动相,检测波长为228nm。结果:平均回收率为99.5％,RSD为0.96％。结论:该方法灵敏,专属,重现性好,可有效控制该制剂的质量。Objective: To establish HPLC method for determining the contents of glimepiride inGlimepiride Capsules. Methods: Using a column packed with ODS and methanol-Ammonium dihydrogenphosphate solution (Ammonium dihydrogen phosphate 1.725g, add water 300ml, adjust the solution withphosphoric acid to pH3.5±0.05) (8:3)as mobile phase,detected at 228nm. Results: The average recov-ery was 99.46%,RSD was 1.82%. There was good linear relationship. Conclusion: The method was sen-sitivc, specific, accurate and suitable for the quality conrtol of the prep aration quality.

关 键 词：格列美脲 反相高效液相色谱法 含量测定 质量控制 降血糖药 

分 类 号：R977.15[医药卫生—药品] R927[医药卫生—药学]