| 高效液相色谱法测定苯扎贝特中的有关物质 |
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| 引用本文： | 黄春森,黄东,李步良. 高效液相色谱法测定苯扎贝特中的有关物质[J]. 中国医疗前沿, 2008, 3(16): 99-100 |
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| 作者姓名： | 黄春森 黄东 李步良 |
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| 作者单位： | 江苏天士力帝益药业有限公司,江苏,淮安,223002 |
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| 摘 要： | 目的建立苯扎贝特中有关物质的测定方法,方法NUCLEOSIL100-5C18(5um)0.125m×4mm;流动相为磷酸二氢钾溶液(2.72g/L,用磷酸调节PH2.3):甲醇=4:6;检测波长:228nm;流速:1.0mL-1min结果苯扎贝特与5个主要杂质能得到有效分离,各杂质在0.2～3.5ug.mL-1范围内呈良好线性关系。结论本测定方法灵敏度高,准确可靠,可以控制苯扎贝特中有关物质的含量。
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| 关 键 词： | 苯扎贝特 有关物质 系统适用性 |
Related substances determination of bezafibrate by HPLC |
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| Affiliation: | HUANG Chun-sen HUANG Dong Jiangsu Tasly Diyi Pharmaceutical CO.; Ltd Huaian 223002.China; |
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| Abstract: | Objective To establish an HPLC method for detection of the related substances.Methods The analytical column was NUCLEOSIL 100-5 C18 column(4.0mm×12.5cm,5μm).The mobile phase was potassium dihydrogen phosphate(2.72g/L,adjust to pH 2.3 with phosphoric acid):methanol = 4:6 The flow rate was 1.0mL·min-1 The wavelenth was 228nm.Results A satisfactory separation condition for the five related impurities,The impurities standard curve was good linear over the range of 0.2~3.5 ug·mL-1.Conclusions The method is sensi... |
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| Keywords: | bezafibrate related substances System suitability |
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