| HPLC法测定达沙替尼片中主药和有关物质的含量 |
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| 引用本文： | 徐家根,赵春才,吴学平,徐康康. HPLC法测定达沙替尼片中主药和有关物质的含量[J]. 中国药房, 2011, 0(1): 56-57 |
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| 作者姓名： | 徐家根 赵春才 吴学平 徐康康 |
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| 作者单位： | 南京医科大学附属南京儿童医院;南京安格医药化工有限公司; |
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| 摘 要： | 目的:建立测定达沙替尼片中主药和有关物质含量的方法。方法:采用高效液相色谱法。色谱柱为Phenomenex Gemini C18,流动相为0.1mol·L-1醋酸铵缓冲液-甲醇(25∶75),流速为1.0mL·min-1,检测波长为248nm,进样量为20μL。结果:达沙替尼与有关物质等分离较好;达沙替尼检测浓度的线性范围为20.0～100.0μg·mL-1(r=0.9999);平均回收率为99.76%(RSD=0.68%);3批样品中有关物质含量为0.13%～0.22%。结论:本方法操作简便、快捷,结果准确、可靠,可用于达沙替尼的质量控制。
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| 关 键 词： | 高效液相色谱法 达沙替尼片 有关物质 含量测定 |
Determination of Dasatinib and Related Substances in Dasatinib Tablets by HPLC |
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| XU Jia-gen,XU Kang-kang ZHAO Chun-cai,WU Xue-ping. Determination of Dasatinib and Related Substances in Dasatinib Tablets by HPLC[J]. China Pharmacy, 2011, 0(1): 56-57 |
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| Authors: | XU Jia-gen XU Kang-kang ZHAO Chun-cai WU Xue-ping |
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| Affiliation: | XU Jia-gen,XU Kang-kang(Nanjing Children's Hospital Affiliated to Nanjing Medical University,Nanjing 210008,China) ZHAO Chun-cai,WU Xue-ping(Nanjing Ange Pharmaceutical Co.,Ltd.,Nanjing 210009,China) |
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| Abstract: | OBJECTIVE：To establish a method for the content determination of dasatinib and related substances in Dasatinib tablets.METHODS：HPLC method was adopted.Dasatinib and the related substances were separated on Phenomenex Gemini C18 ; the mobile phase was 0.1 mol·L -1 ammonium acetate buffer-methanol（25∶75）with flow rate at 1.0 mL·min -1 .The detection wavelength was 248 nm and the sample size was 20μL.RESULTS：Dasatinib and the related substances were well-separated.The linear range of dasatinib was 20.0～100.0μg·mL（r=0.999 9）with an average recovery of 99.76%（RSD=0.68%）.The content of related substance in 3 batches of samples were 0.13%～0.22%.CONCLUSION：This method is rapid,accurate and reliable,and it is applicable for the quality control of dasatinib. |
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| Keywords: | HPLC Dasatinib tablet Related substance Content determination |
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