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高效液相色谱法测定磷酸奥司他韦的含量和有关物质 被引量：2

Determination of oseltamivir and related substances in oseltamivir by HPLC
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摘要 目的建立测定磷酸奥司他韦原料药的含量及有关物质的高效液相色谱法.方法采用Luna C8色谱柱,甲醇-0.03moL.L-1磷酸二氢钠(55:45,磷酸调节pH至3.5±0.1)为流动相,检测波长为220nm,柱温为30℃流速1.0 mL.min-1.结果磷酸奥司他韦在1.0～1000.0μg.mL-1范围内,线性关系良好(r=0.9996),有关物质的限量为2.0%.结论所建方法简便、准确、专属性好,可用于磷酸奥司他韦原料药的含量及其有关物质的测定. Objective： To establish an RP-HPLC for determination of oseltamivir and related substances in oseltamivir Method： Oseltamivir and related substances are determinated on HPLC instrument fixed a Luna C8 column （150mm×4.6mm,5um） with UV detection at 220nm, and the mobile phase consists of phosphoric buffer （0.03moL.Lt NaH2PO4） and methyl alcohol （55：45, adjusted to pH3.5±0.1 with phosphoric acid）, the flow rate is 1.0 ml.min-1 - the column oven is maintained at 50℃. Results： The calibration curve is linear （r = 0.9996） within the range of 1.0- 1000.0 ug.mL-1 for oseltamivir, the average recovery rate is from 99.6% to 100.9% for three different levels of the amount of oseltamivir. The limit of related substances is 2.0%. Conclusion： This method is simple, quick, accurate and effective for testing related compounds in oseltamivir and for its contents determination. This method is suitable for the quality control for oseltamivir.
作者 李婧 羊玥颖 赵丽娜 夏宏蕊 李晓倩 向俞涛
机构地区 西南民族大学化学与环境保护工程学院
出处 《西南民族大学学报（自然科学版）》 CAS 2011年第2期254-256,共3页 Journal of Southwest Minzu University(Natural Science Edition)
基金 西南民族大学2010年学生创新项目
关键词 磷酸奥司他韦 HPLC 含量测定 有关物质 oseltamivir HPLC related substance contents determination
分类号 R914 [医药卫生—药物化学] R927 [医药卫生—药学]
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参考文献10

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西南民族大学学报（自然科学版）
2011年 第2期

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