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RP-HPLC法测定复方马来酸罗格列酮/格列美脲片中两组分的含量
引用本文:于秀丽,宋修丽,解春文.RP-HPLC法测定复方马来酸罗格列酮/格列美脲片中两组分的含量[J].中国医药技术经济与管理,2008,2(9):58-61.
作者姓名:于秀丽  宋修丽  解春文
作者单位:1. 山东达因海洋生物制药股份有限公司,威海,264300
2. 荣成益成医院药剂科,威海,264300
摘    要:目的建立用RP-HPLC法测定复方马来酸罗格列酮/格列美脲片中罗格列酮和格列美脲的含量。方法色谱柱为Thermo C18柱(4.6mm×250mm,10μm);乙腈-磷酸二氢铵(用磷酸调pH3.0)=55:45;流速1.0ml/min;检测波长232nm,柱温(40±2)℃。结果马来酸罗格列酮进样量在3.2~4.8μg范围内有良好的线性关系,回归方程为y=15121x+312.92相关系数为r=0.9994(n=5);格列美脲进样量在1.6~2.4μg范围内有良好的线性关系,回归方程为y=5621x+230相关系数r=0.9998(n=5)。结论该检测方法简便准确,可用于复方马来酸罗格列酮/格列美脲片的质量控制。

关 键 词:RP-HPLC  马来酸罗格列酮  格列美脲  含量

RP-HPLC determination of of two components in compound maleate rosiglitazone and glimepiride tablets
Yu Xiu-li,Song Xiu-li,Xie Chun-wen.RP-HPLC determination of of two components in compound maleate rosiglitazone and glimepiride tablets[J].Chinese Journal of Pharmacentical Technolgy Economics & Management,2008,2(9):58-61.
Authors:Yu Xiu-li  Song Xiu-li  Xie Chun-wen
Institution:YU Xiuli, SONG Xiuli, XIE Chunwen(Shah Dong dyne Pharmaceutical Co.Ltd, Weihai,264300; 2.Ronfcheng yicheng Hospital, Weihai 264300; 3.hart Dong dyne Phattnaceutical Co.Ltd, Weihai 264300, China)
Abstract:Objective To establish RP-HPLC method for determination the contents of maleate rosiglitazone and glimepiride in compound maleate rosiglitazone and glimepiride tablets. Method The chromatographic column of Thermo C18 column (4.6 × 250mm, 10μ m) was used. The mobile phase consisted of acetonitrile-ammonium phosphate disbasic (adjust pH to 3.0with phosphoric acid.) (55:45); The flow rate was 1ml · min^-1. The detection wavelength : 232nm; The column temperature was 40 ± 2℃. Result The calibration curves was in the ranges of 3.2 μg to 4.8μ g (r=0.999 4, n=5) for maleate rosiglitazone and 1.6μ g to 2.4 μ g (r=0.999 8, n=5) for glimepiride; Conclusion The method was accurate, simple and can be used to determine the contents of two components in maleate rosiglitazone and glimepiride tablets.
Keywords:RP-HPLC
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