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HPLC法测定尼索地平缓释胶囊的有关物质

Determination of related substances in Nisoldipine Sustained Release Capsules by HPLC

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【作者】 刘敏李闻涛同卓斌刘俊田

【Author】 LIU Min1,2,LI Wentao3,TONG Zhuobin4,LIU Juntian1(1.College of Medicine,Xi′an Jiaotong University,Xi′an 710061,China;2.Xi′an Haixin Pharmaceutical Co.Ltd.,Xi′an 710075,China;3.Xi′an Wanlong Pharmaceutical Company.Ltd,Xi′an 710119,China;4.Traditional Chinese Medicine Research Institute of Shaanxi,Xianyang 712000,China)

【机构】 西安交通大学医学院西安海欣制药有限公司西安万隆制药股份有限公司陕西中药研究所

【摘要】 目的建立高效液相色谱法测定尼索地平缓释胶囊的有关物质。方法采用Irregular ODS-C18色谱柱(250mm×4.6mm,10μm);流动相:甲醇-水(70∶30);流速1.0mL·min-1;检测波长234nm。结果 HPLC法测定的线性范围为0.04~0.8mg·mL-1,相关系数r为0.999 9,该方法的重复性好(RSD=0.61%)。结论建立的方法快速、灵敏、准确,适用于尼索地平缓释胶囊中的有关物质测定。

【Abstract】 Objective To establish a method for the determination of related substances in Nisoldipine Sustained Release Capsules by HPLC.Method Irregular ODS-C18 column(250 mm×4.6 mm,10 μm) was used,the mobile phase was methanol-water(70∶30),and the flow rate was 1.0 mL·min-1.The detection wavelength was 234 nm.Results There was a good linear relationship within the range of 0.04-0.8 mg·mL-1(r=0.999 9).The reproducibility of the method was good with RSD 0.61%.Conclusion The method is rapid,sensitive,and accurate,and could be used for the determination of the related substances in Nisoldipine Sustained Release Capsules by HPLC.

【关键词】 尼索地平有关物质高效液相色谱法
【Key words】 nisoldipinerelated substancesHPLC
  • 【文献出处】 西北药学杂志 ,Northwest Pharmaceutical Journal , 编辑部邮箱 ,2012年04期
  • 【分类号】R927.2
  • 【下载频次】71
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