| RP-HPLC法测定凡德他尼片中主药和有关物质的含量 |
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| 引用本文： | 赵玲,赵春才,杨博,刘艳艳,张露.RP-HPLC法测定凡德他尼片中主药和有关物质的含量[J].中国药房,2012(29):2759-2760. |
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| 作者姓名： | 赵玲 赵春才 杨博 刘艳艳 张露 |
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| 作者单位： | [1]武汉工业学院生物与制药工程学院,武汉430023 [2]南京科瑞翔医药科技有限公司,南京210019 [3]南京安格医药化工有限公司,南京210009 |
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| 摘 要： | 目的:建立测定凡德他尼片中主药和有关物质含量的方法。方法:采用反相高效液相色谱法。色谱柱为KromasilC18,流动相为0.05mol·L-1醋酸铵缓冲液-甲醇(30∶70,pH8.0),流速为1.0mL·min-1,检测波长为247nm,进样量为20μL。结果:凡德他尼检测浓度的线性范围为20.05～180.4μg·mL-(1r=0.9999);平均回收率为99.40%(RSD=0.56%),定量限为4ng。结论:本方法操作简便、快捷,结果准确、可靠,可用于凡德他尼片的质量控制。
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| 关 键 词： | 凡德他尼片 反相高效液相色谱法 有关物质 含量测定 |
Content Determination of Main Components and Related Substances in Vandetanib Tablets by RP-HPLC |
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| ZHAO Ling School of Biology and Pharmaceutical Engineering,Wuhan Polytechnic University,Wuhan,China ZHAO Chun-cai,LIU Yan-yan,ZHANG Lu.Content Determination of Main Components and Related Substances in Vandetanib Tablets by RP-HPLC[J].China Pharmacy,2012(29):2759-2760. |
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| Authors: | ZHAO Ling School of Biology and Pharmaceutical Engineering Wuhan Polytechnic University Wuhan China ZHAO Chun-cai LIU Yan-yan ZHANG Lu |
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| Institution: | (Nanjin Keruixiang Pharmaceutical Co., Ltd., Nanjing 210019, Chi- na) YANG Bo(Nanjing Ange Pharmaceutical Co., Ltd., Nanjing 210009, China) |
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| Abstract: | OBJECTIVE： To establish a method for the content determination of main components and related substances in Vandetanib tablets. METHODS： RP-HPLC method was adopted. The determination was performed on Kromasil C18 column with mobile phase consisted of 0.05 mol·L^-1 acetate buffer-methanol （30：70, adjusting pH to 8.0） at the flow rate of 1.0 mL·min^-1. The detection wavelength was set at 247 nm and injection volume was 20 μL. RESULTS： The linear range of vandetanib was 20.05-180.4μg·mL^-1（r=0.999 9） with an average recovery of 99.40% （RSD=0.56%）, and LOQ was 4 ng. CONCLUSION： The method is simple, rapid, accurate and reliable, and it is applicable for the quality control of Vandetanib tablets. |
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| Keywords: | Vandetanib tablet RP-HPLC Related substance Content determination |
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