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HPLC法测定盐酸帕唑帕尼片含量和有关物质
引用本文:赵玲,赵春才,杨博,刘艳艳,施琳.HPLC法测定盐酸帕唑帕尼片含量和有关物质[J].中国药房,2012(33):3138-3139.
作者姓名:赵玲  赵春才  杨博  刘艳艳  施琳
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
摘    要:目的:建立测定盐酸帕唑帕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KromasilC18,流动相为乙腈-0.02mol·L-1醋酸铵缓冲液(35:65),流速为1.0mL·min-1,检测波长为268nm,柱温为25℃,进样量为20μL。结果:盐酸帕唑帕尼检测浓度线性范围为40.18~361.6μg·mL-1(r=0.9999),检测限为2ng,平均回收率为99.60%,RSD=0.53%(n=9)。结论:该方法操作简便、快捷、准确、可靠,可用于盐酸帕唑帕尼片的质量控制。

关 键 词:盐酸帕唑帕尼片  有关物质  含量测定  高效液相色谱法

Content Determination of Main Component and Related Substances in Pazopanib Hydrochloride Tablets by HPLC
ZHAO LingSchool of Biology and Pharmaceutical Engineering,Wuhan Polytechnic University,Wuhan,China ZHAO Chun-cai,LIU Yan-yan,SHI Lin.Content Determination of Main Component and Related Substances in Pazopanib Hydrochloride Tablets by HPLC[J].China Pharmacy,2012(33):3138-3139.
Authors:ZHAO LingSchool of Biology and Pharmaceutical Engineering  Wuhan Polytechnic University  Wuhan  China ZHAO Chun-cai  LIU Yan-yan  SHI Lin
Institution:(Nanjing Keruixiang Pharmaceutical Co.,Ltd.,Nanjing 210019,China) YANG Bo(Nanjing Ange Pharmaceutical Co.,Ltd.,Nanjing 210009,China)
Abstract:OBJECTIVE:To develop a method for the content determination of main component and related substances in Pazopanib hydrochloride tablets.METHODS:HPLC method was adopted.The determination was performed on Kromasil C18 column with mobile phase composed of acetonitrile-0.02 mol·L-1 ammonium acetate solution(35:65) at the flow rate of 1.0 mL·min-1.The detection wavelength was set at 268 nm at 25 ℃.The injection size was 20 μL.RESULTS:The linear range of pazopanib hydrochloride was 40.18~361.6 μg·mL-1(r=0.999 9).The detection limit was 2 ng and average recovery rate was 99.60%(RSD=0.53%,n=9).CONCLUSION:The method is simple,rapid,accurate and reliable,and it is applicable for the quality control of Pazopanib hydrochloride tablets.
Keywords:Pazopanib hydrochloride tablets  Related substance  Content determination  HPLC
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