| HPLC法测定多尼培南原料药含量及有关物质 |
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| 引用本文： | 王炳璋,曲昌海,闫汝锋,王雨鑫,张师愚.HPLC法测定多尼培南原料药含量及有关物质[J].中国药房,2012(29):2748-2750. |
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| 作者姓名： | 王炳璋 曲昌海 闫汝锋 王雨鑫 张师愚 |
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| 作者单位： | [1]天津中医药大学,天津300193 [2]北京中医药大学,北京100029 [3]北京人福军威医药技术开发有限公司,北京102600 |
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| 摘 要： | 目的:建立测定多尼培南原料药含量及有关物质的方法。方法:采用高效液相色谱法。色谱柱为ApolloC18,流动相为甲醇-0.02mol·L-1KH2PO4(H3PO4调pH至3.0)=12∶88,主药与有关物质检测波长分别为297、220nm,流速为1.0mL·min-1,柱温为30℃,进样量为20μL。结果:多尼培南检测浓度线性范围分别为20.0～200.0μg·mL-(1r=0.9999),平均回收率为101.39%(RSD=0.63%,n=9),检测限为20ng·mL-1。结论:该方法简便、灵敏度高、重复性好,可用于多尼培南原料药含量测定和有关物质检查。
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| 关 键 词： | 多尼培南 高效液相色谱法 含量测定 有关物质 |
Content Determination of Doripenem and Its Related Substances by HPLC |
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| WANG Bing-zhang,WANG Yu-xin,ZHANG Shi-yu.Content Determination of Doripenem and Its Related Substances by HPLC[J].China Pharmacy,2012(29):2748-2750. |
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| Authors: | WANG Bing-zhang WANG Yu-xin ZHANG Shi-yu |
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| Institution: | (Tianjin University of Traditional Chinese Medicine, Tian- jin 300193, China) QU Chang-hai(Beijing University of Traditional Chinese Medicine, Beijing 100029, China) YAN Ru-feng(Beijing Human-well Junwei Pharmaceutical Tech Co., Ltd., Beijing 102600, China) |
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| Abstract: | OBJECTIVE： To establish a method for the content determination of doripenem and its related substances. METH-ODS： HPLC method was adopted. The determination was performed on Apollo C18 column with mobile phase consisted of metha-nol-0.02 mol.L-1 KH2PO4 buffer （H3PO4 adjusting pH to 3.0） （12：88） at the flow rate 1.0 mL·min^-1. The detection wavelength of main components was 297 mn and that of related substances was 220 ran. The column temperature was 30 ℃ and injection volume was 20 μL. RESULTS： The linear range of doripenem was 20.0-200.0μg·mL^-1 （r=0.999 9） with an average recovery of 101.39% （RSD：0.63%, n：9）. The lowest limit of detection was 20 ng·mL^-1. CONCLUSION： The method is convenient with high sensitivity and repeatability. It can be used for the content determination of doripenem and its related substances. |
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| Keywords: | Doripenem HPLC Content determination Related substances |
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