| 梯度洗脱HPLC法测定甲磺酸伊马替尼含量及有关物质 |
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| 引用本文： | 王棋,宋锐,费梦莹,严拯宇.梯度洗脱HPLC法测定甲磺酸伊马替尼含量及有关物质[J].海峡药学,2012,24(3):58-60. |
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| 作者姓名： | 王棋 宋锐 费梦莹 严拯宇 |
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| 作者单位： | 1. 中国药科大学分析化学教研室 南京211198
2. 中国药科大学分析化学教研室 南京211198;中国药科大学药物质量与安全预警教育部重点实验室 南京211198 |
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| 摘 要： | 目的建立甲磺酸伊马替尼原料药含量测定和有关物质检查方法。方法采用Herdera C18（5μm,4.6mm×250mm）色谱柱,甲醇-辛烷磺酸钠水溶液,梯度洗脱,流速为1mL.min-1,检测波长为267nm,进样体积为20μL,柱温为40℃。结果在选定色谱条件下,主要合成的中间体和各降解产物可以完全分离。线性范围8.12～81.20μg.L-1（r=0.9999）,检测限为0.02μg.mL-1。结论所用方法准确、灵敏、可靠。
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| 关 键 词： | 甲磺酸伊马替尼 有关物质 含量测定 HPLC |
Determination of imatinib mesylate and related substances by gradient elution HPLC |
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| WANG Qi
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SONG Rui
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FEI Meng-ying
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YAN Zheng-yu.Determination of imatinib mesylate and related substances by gradient elution HPLC[J].Strait Pharmaceutical Journal,2012,24(3):58-60. |
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| Authors: | WANG Qi SONG Rui FEI Meng-ying YAN Zheng-yu |
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| Institution: | 1.Department of Analytical Chemistry,China Pharmaceutical University,Nanjing 211198 China;2.Key Laboratory of Drug Quality Control and Pharmacovigilance,Ministry of Education,Nanjing 211198,China) |
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| Abstract: | OBJECTIVE A method for determination of Imatinib mesylate and related substances was established.METHODS The liquid chromatography was carried out using a Herdera C18（5μm,4.6mm×250mm）column.The mobile phase consisted of methanol-solution of 1-octanesulfonic acid sodium salt（36mmol·L-1）,gradient elution.The flow rate was 1mL·min-1.The detection wavelength was 278nm.The injection volume was 20μL.The column temperature was 40℃.RESULTS The intermediates and degraded substances could be separated.Three batches of sample were determined.The calibration curve for Imatinib mesylate was linear in the range of 8~80μg·L-1（r=0.9999）.The detection limit for Imatinib mesylate was 0.02μg·mL-1.CONCLUSION The method is specific,accurate,sensitive,simple,and can be used for quality control of Imatinib mesylate. |
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| Keywords: | Imatinib mesylate Related substances Determination HPLC |
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