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| HPLC测定米格列奈钙原料药的含量及有关物质 | |
| 引用本文： | 刘伦德,聂丽华,周亚球. HPLC测定米格列奈钙原料药的含量及有关物质[J]. 安徽医药, 2010, 14(3): 291-293. DOI: 10.3969/j.issn.1009-6469.2010.03.017 |
| 作者姓名： | 刘伦德 聂丽华 周亚球 |
| 作者单位： | 安徽省舒城县人民医院,安徽,舒城,231300;安徽中医学院药学院,安徽,合肥,230031 |
| 摘 要： | 目的用HPLC法测定米格列奈钙原料药的含量及有关物质，为米格列奈钙原料药的含量和有关物质测定提供检测方法，制定指控标准。方法Alhech C18色谱柱（250mm×4．6mm，5μm），采用乙腈-水（55：45）用稀磷酸调pH=2．5作为流动相，检测波长：210nm，流速：0．8ml·min^-1。结果主峰能与相邻杂质峰较好分离，浓度在3．38—33．8mg·L^-1的范围内，米格列奈钙的峰面积和浓度有良好的线性关系，r=0．9999。结论该方法简便、专属性好、灵敏度高，可用于米格列奈钙的含量及有关物质测定的需要。 |
| 关 键 词： | 高效液相法 米格列奈钙 含量测定 有关物质 |
HPLC determination of mitiglinide calcinm and its related substances |
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| LIU Lun-de,NIE Li-hua,ZHOU Ya-qiu. HPLC determination of mitiglinide calcinm and its related substances[J]. Anhui Medical and Pharmaceutical Journal, 2010, 14(3): 291-293. DOI: 10.3969/j.issn.1009-6469.2010.03.017 | |
| Authors: | LIU Lun-de NIE Li-hua ZHOU Ya-qiu |
| Affiliation: | LIU Lun-de1,NIE Li-hua2,ZHOU Ya-qiu2 |
| Abstract: | Aim To establish an HPLC method for the determination of mitiglinide calcium and its related substances.Methods Alltech C 18column(250 mm ×4.6 mm,5 μm),was adopted,with a mobile phase of acetonitrile H 2O(55:45)(pH adjusted to 2.5 with phosphoric acid).The flow rate was 0.8 ml·min-1,and the detected wavelength was 210 nm.Results Mitiglinide calcium was completely separated from impurities.The calibrated linear curve was from 3.38 mg·L-1 to 33.8 mg·L-1(r=0.9999).Conclusion The method was accurate and reliable.It is applicable for the quality control of mitiglinide and its related substances. |
| Keywords: | HPLC mitiglinide calcium determination related substance |
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