| HPLC法测定唑来膦酸含量及有关物质 |
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| 引用本文： | 戚宝和,贾佳,除锁平.HPLC法测定唑来膦酸含量及有关物质[J].中国当代医药,2011,18(36):46-47. |
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| 作者姓名： | 戚宝和 贾佳 除锁平 |
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| 作者单位： | 1. 江苏省兴化市人民医院药剂科,江苏兴化,225700
2. 江苏奥赛康药业有限公司,江苏南京,211112 |
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| 摘 要： | 目的：建立唑来膦酸的HPLC含量测定及有关物质检查方法。方法：采用ShimPackCLC-ODS不锈钢柱（150×4.6mm,5μm）,以0.08%冰醋酸溶液（用三乙胺调pH至3.5）-0.1%四丁基氢氧化铵溶液（10：1）为流动相,流速1.0ml/min,检测波长211nm。进样量为20μL。结果：唑来膦酸进样量在1.5～15.5μg范围内具有良好的线性关系（r=0.9999,n=5）,检测限为0.015μg/mL。结论：本方法分离效果好,准确、可靠、精密。
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| 关 键 词： | 高效液相色谱 唑来膦酸 有关物质 含量 |
HPLC determination of content and related substances of zoledronic acid |
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| Authors: | QI Baohe JIA Jia XU Suoping |
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| Institution: | 1.Department of pharmacy,the People’s Hospital of Xinghua City in Jiangsu Province,Xinghua 225700,China;2.Jiangsu AoSaiKang Pharmaceutical CO.,LTD.,Nanjing 211112,China |
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| Abstract: | Objective： To establish a method for the determination of content and related substances of zoledronic acid by HPLC. Methods： A ShimPack CLC-ODS （150×4.6 mm, 5 μm） column was used as anylytical column with a mobile phase consisted of 0.08% acetic acid （adjust to pH 3.5 with triethylamine） -0.1% tetrabutylammonium hydroxiede （10：1）, the flow rate was 1.0 ml/min, the detection wavelength was 211 nm. Result： The linear range of zoledronic acid was 1.5-15.5 μg （r=0.999 9, n=5）, the lowest linit was 0.015 μg/ml. Conclusion： This method is accurate,sensitive, and precise. |
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| Keywords: | HPLC Zoledronic acid Related substance Content |
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