高效液相色谱法测定消渴平胶囊中格列苯脲含量  

Determination of Glibenclamide in Xiaokeping Capsules by HPLC

作　　者：刘淑花[1] 田华 

机构地区：[1]山东省烟台市烟台山医院,山东烟台264008 [2]烟台中亚药业有限责任公司,山东烟台264000

出　　处：《中国药业》2010年第23期24-25,共2页China Pharmaceuticals

摘　　要：目的建立测定消渴平胶囊中格列苯脲含量的高效液相色谱法。方法色谱柱采用Kromasil C18柱(200mm×4.6mm,5μm),流动相为磷酸二氢铵溶液(取磷酸二氢铵1.725g,加300mL水溶解,用磷酸调pH至3.5±0.05)-甲醇(35:65),检测波长230nm,进样量20μL。结果格列苯脲质量浓度在7.8～62.4μg/mL范围内与峰面积线性关系良好,r=0.9999(n=6);平均加样回收率为99.85%,RSD为1.73%(n=9)。结论高效液相色谱法简便、准确,重现性好,可用于控制消渴平胶囊中格列苯脲的含量。Objective To establish an HPLC method for the determination of glibenclamide in Xiaokeping Capsules.Methods The chromatographic column was Kromasil C18 column（200 mm × 4.6 mm,5 μm） with ammonium dihydrogen phosphate solution（dissolving 1.725 g NH4H2PO4 in 300 mL water and adjusting to 3.5 ± 0.05 with PH phosphoric acid）-methanol（35：65） as the mobile phase.The detection wavelength was 230 nm.The sample size was 20 μL.Results The calibration curve was linear in the range of 7.8-62.4 μg /mL（r = 0.999 9）.The average recovery rate was 99.85%,RSD was 1.73%.Conclusion The method is accurate and reliable with good reproducibility,which can be used for the content control of glibenclamide in Xiaokeping Capsules.

关 键 词：高效液相色谱法 消渴平胶囊 格列苯脲 含量测定 

分 类 号：R927.2[医药卫生—药学] R977.15