消糖灵片和消糖灵胶囊中格列本脲含量及含量均匀度测定  

Determination of Glibenclamide and Its Content Uniformity in Xiaotangling Tablets and Xiaotangling Capsules

作　　者：贺凡珍 黄财顺 杨娟 李哲 许润娟 HE Fan-zhen;HUANG Cai-shun;YANG Juan;LI Zhe;XU Run-juan(Zhongshan Institute of Food and Drug Control,Zhongshan 528437,China)

机构地区：[1]中山市食品药品检验所,广东中山528437

出　　处：《食品与药品》2019年第4期279-283,共5页Food and Drug

摘　　要：目的采用高效液相色谱法(HPLC)测定消糖灵片和消糖灵胶囊中格列本脲的含量及含量均匀度,从而评价不同厂家产品的质量现状及存在问题。方法采用Agilent ZORBAX SB-Aq色谱柱(4.6 mm×250 mm,5μm),以甲醇-磷酸二氢铵溶液(取磷酸二氢铵1.725 g,加水300 ml使溶解,用磷酸调pH至3.5)(68:32)为流动相,流速1.0 ml/min,检测波长230 nm。结果格列本脲的线性范围为2.91~58.26μg/ml,格列本脲的平均回收率(n=9)为99.9%,RSD为1.2%。结论消糖灵片中格列本脲的质量控制较均一稳定,消糖灵胶囊中格列本脲的质量控制参差不齐,其现行标准应进一步提高,以保证该药物的安全性和有效性。Objective To establish an HPLC method for the determination of glibenclamide and its content uniformity in Xiaotangling Tablets and Xiaotangling Capsules,and evaluate the quality status and existing problems of products from different manufacturers.Methods Agilent ZORBAX SB-Aq column(4.6 mm×250 mm,5μm)was adopted.The mobile phase was methanol-ammonium dihydrogen phosphate solution(dissolving 1.725 g of NH4H2PO4 in 300 ml of water,and adjusting pH of the solution to 3.5 with phosphoric acid)(68:32)at a flow rate of 1.0 ml/min and the detection wavelength was 230 nm.Results The linear range of glibenclamide was 2.91-58.26μg/ml.The average recovery(n=9)of glibenclamide was 99.9%,with RSD of 1.2%.Conclusion Compared with Xiaotangling Capsules,the quality of glibenclamide in tablets is more uniform and stable.The current standard of Xiaotangling Capsules should be further improved to ensure the safety and effectiveness of the drug.

关 键 词：消糖灵片 消糖灵胶囊 格列本脲 含量测定 含量均匀度 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]