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| 高效液相色谱法测定米格列奈钙原料药的有关物质 | |
| 引用本文： | 曾檀,霍丹群,周祥敏,程辉跃.高效液相色谱法测定米格列奈钙原料药的有关物质[J].中国药业,2013,22(17):28-29. |
| 作者姓名： | 曾檀 霍丹群 周祥敏 程辉跃 |
| 作者单位： | 1. 重庆大学生物工程学院,重庆400030;重庆市食品药品检验所,重庆 401121;重庆市药物过程与质量控制工程技术研究中心,重庆401121 2. 重庆大学生物工程学院,重庆,400030 3. 重庆市食品药品检验所,重庆 401121;重庆市药物过程与质量控制工程技术研究中心,重庆401121 |
| 摘 要： | 目的 建立米格列奈钙原料药的有关物质检测方法.方法 采用高效液相色谱法,Zorbax SB C18色谱柱(250 mm×4.6mm,5μm),以乙腈-0.01 mol/L KH2PO4(用磷酸调节pH至2.5,40∶60)为流动相,检测波长210 nm,流速1.0 mL/min.结果 米格列奈主峰能与相邻杂质峰有效分离.结论 该方法简便、准确,适用于米格列奈钙有关物质的检测,可用于米格列奈钙的质量控制. |
| 关 键 词： | 米格列奈钙 有关物质 高效液相色谱法 |
Determination of Related Substances of Mitiglinide Calcium by HPLC |
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| Zeng Tan , Huo Danqun , Zhou Xiangmin , Cheng Huiyue.Determination of Related Substances of Mitiglinide Calcium by HPLC[J].China Pharmaceuticals,2013,22(17):28-29. | |
| Authors: | Zeng Tan Huo Danqun Zhou Xiangmin Cheng Huiyue |
| Affiliation: | 1. College of Bioengineering, Chongqing University, Chongqing, China 400030; 2. Chongqing Municipal Institute for Food and Drug Control Chongqing, China 401121; 3. Chongqing Research Center for Drug Process and Quality Control Engineering and Technique, Chongqing, China 401121) |
| Abstract: | Objective To establish a HPLC method for determining the related substances of mitiglinide calcium. Methods The HPLC method was adopted with the Zorbax SB-C18 column （250 mm ×4.6 mm, 5 μm） and the mobile phase of acetonitrile-0. 01 mol/L monopotassium phosphate solution （adjusting to pH =2.5 with phosphoric acid,40 ： 60）. The detection wavelength was 210 nm. The flow rate was 1.0 mL/min. Results The mitiglinide main peak was effectively separated from adjacent impurity peaks. Conclusion This method is simple, accurate and suitable for determining the related substances of mitiglinide calcium, which can be used to control the quality of mitiglinide calcium. |
| Keywords: | mitiglinide calcium related substance I-IPLC |
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