| HPLC法测定左乙拉西坦片的右旋异构体 |
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| 引用本文： | 付建,苏贵勇,赵海桥,赵永娟.HPLC法测定左乙拉西坦片的右旋异构体[J].山东化工,2014(4):87-87,91. |
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| 作者姓名： | 付建 苏贵勇 赵海桥 赵永娟 |
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| 作者单位： | 山东方明药业集团股份有限公司,山东菏泽274500 |
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| 摘 要： | 目的:采用HPLC法测定左乙拉西坦片的右旋异构体。方法:采用CHIRALPAK AD-H(5μm,4.6×250mm)色谱柱,以正己烷-无水乙醇(80:20)为流动相,流速为1.0mL/min,检测波长为215nm,柱温为30℃。结果:在该色谱条件下,左乙拉西坦与其右旋体分离度良好,其右旋体在0.00525~0.105 mg·mL-1范围内与峰面积的线性关系良好(r=0.99997),最低检测限为5ng,定量限为12ng。结论:该方法专属性强、灵敏度高、重复性好,可用于左乙拉西坦片的质量控制。
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| 关 键 词： | 左乙拉西坦片 右旋体 HPLC |
Determination of Dextro Iomer in Levetiracetam Tablets by HPLC |
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| FU Jian,SU Gui-yong,ZHAO Hai-qiao,ZHAO Yong-juan.Determination of Dextro Iomer in Levetiracetam Tablets by HPLC[J].Shandong Chemical Industry,2014(4):87-87,91. |
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| Authors: | FU Jian SU Gui-yong ZHAO Hai-qiao ZHAO Yong-juan |
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| Affiliation: | (Shandong Fangming Pharmaceutical Co. , Ltd. , Heze 274500, China) |
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| Abstract: | Objective to develop an HPLC method for determination of dextro isomer in Levetiracetam Tablets. Methods the C HIRALPAK AD- H （5 μm ,4.6 × 250mm）was used with the mobile phase of n- hexane- dehydrated alcohol （80：20）. The flow rate was 1.0mL/min, the wavelength used for detection 215nm and the column temperature was at 30℃. Results Under the chromatograph conditions adopted, Levetiracetam and its dextroisomer separation good, the calibration curve for Levetiraeetam dextro isomer exhibited an excellent linear. |
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