| 多索茶碱注射液的质量控制 |
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| 引用本文： | 梁军.多索茶碱注射液的质量控制[J].齐齐哈尔轻工业学院学报,2012(4):9-12. |
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| 作者姓名： | 梁军 |
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| 作者单位： | 齐齐哈尔大学化学与化学工程学院,黑龙江齐齐哈尔161006 |
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| 摘 要： | 规范多索茶碱注射液检验标准操作程序。在原有检验操作程序的基础上，建立高效液相法测定多索茶碱注射液有关物质的检测方法。含量测定采用Phenomenex-C18（250×4．60mm5μm）色谱柱，流动相：乙腈一磷酸盐缓冲盐pH=5．8（18：82），流速0．8mL·min^-1，检测波长273nm，进样量10laL，RSD=0．11％。有关物质测定采用Phenomenex-c18（250×4．60mm5ttrn）色谱柱，流动相：乙腈一水（V（以乙腈）：V（水）=（35：65）），流速0．8mL·min^-1，检测波长273nm，进样量10μL。本方法简便、快速、结果准确、可靠。
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| 关 键 词： | 多索茶碱注射液 质量控制 高效液相色谱法 |
Quality evaluation of Doxofylline for injection |
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| Authors: | LIANG Jun |
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| Affiliation: | LIANG Jun ( College of Chemistry and Chemical Engineering, Qiqihar University, Heilongjiang Qiqihar 161006, China ) |
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| Abstract: | Standaidising testing procedures of Doxofylline for Injection. On the original testing procedures, a determination method of doxofylline for injection and its related substances was established. In content determination, a H13827-4 C18 column was used, and the mobile phase was acetonitril and phosphate buffer （ pH5.8 ） （ 18 ： 82 ） . Control the velocity at 0.8mL. min-1 and the detective wavelength was 273nm. The relative standard deviation （ RSD ） was 1.1%. in addition to the mobile phase,whose is acetonitrile - water （ 35 ： 65 ） , the chromatographic conditions of related substances was the same as the content determination.This method is simple, rapid, accurate and reliable. |
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| Keywords: | Doxofylline injection quality evaluation HPLC |
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