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Determination of glipizide concentration in human plasma by LC-MS/MS and bioequivalence study of its controlled release preparation
Author(s): 
Pages: 81-84,110
Year: Issue:  2
Journal: Qilu Pharmaceutical Affairs

Keyword:  液相色谱-串联质谱法格列吡嗪生物等效性;
Abstract: 目的 建立测定人血浆中格列吡嗪浓度的液相色谱-串联质谱(LC-MS/MS)方法 ,并将其应用到格列吡嗪控释剂的生物等效性预试验.方法 24名健康受试者分为空腹组和餐后组,按照双周期、双顺序、交叉设计分别口服受试制剂和参比制剂5 mg,采用液相色谱-串联质谱方法 测定血药浓度,色谱柱为Phenomenex Kinetex C18柱(2.1 mm×50 mm,2.6μm),流动相为0.1%甲酸水-纯乙腈,在正离子模式下进行多反应监测(MRM),分析物离子对为446.1/321.1,内标为457.1/321.1.用WinNonlin 6.4软件统计分析药动学参数.结果 格列吡嗪在2~300 ng·mL-1浓度范围内线性良好.空腹试验中受试制剂与参比制剂的Cmax分别为105.71±35.85和100.68±39.77μg·L-1,AUC0~t分别为2521.98±1259.08和2437.48±1169.01μg·h·L-1,AUC0~∞分别为2717.64±1518.59和2658.65±1373.10μg·h·L-1,Tmax分别为19.33±7.00和15.00±8.33 h,t1/2分别为7.39±4.27和7.94±5.13 h.餐后试验中受试制剂与参比制剂的Cmax分别为137.88±76.29和144.68±68.65μg·L-1,AUC0~t分别为2439.03±1510.10和2603.74±1610.66μg·h·L-1,AUC0~∞分别为2562.27±1532.94和2699.02±1704.75μg·h·L-1,Tmax分别为11.70±5.23和9.90±2.08 h,t1/2分别为8.38±3.48和6.27±2.68 h.主要药动学参数无显著性差异.结论 该方法 灵敏、快速,具有较高的临床适用性,两种片剂在空腹和餐后条件下均具有生物等效性.
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