| HPLC法测定注射用奥扎格雷钠的含量 |
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| 引用本文： | 徐小梅,程庆兵.HPLC法测定注射用奥扎格雷钠的含量[J].安徽卫生职业技术学院学报,2013(5):84-85,79. |
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| 作者姓名： | 徐小梅 程庆兵 |
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| 作者单位： | [1]安徽中医药大学第一附属医院,合肥230031 [2]合肥市食品药品监督检验所,安徽238000 |
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| 摘 要： | 目的：建立注射用奥扎格雷钠的含量测定方法。方法：采用HPLC法，以十八烷基硅烷键合硅胶为填充剂，乙腈-0．25mol／L的磷酸缓冲液溶液（15：85）为流动相，检测波长为277nm，流速为1．0ml／min。结果：奥扎格雷钠在4．09～16．36μ∥ml范围内线性关系良好，相关系数为r=0．9999（n=6），平均回收率为99．5％（KSD=0．28％，n=9）。结论：HPLC法测定注射用奥扎雷钠含量的方法准确可靠，重现性好，可作为该制剂质量控制的方法。
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| 关 键 词： | 注射用奥扎格雷钠 奥扎格雷钠 高效液相色谱法 含量测定 |
Content determination of Ozagrel Sodium for injection by HPLC method |
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| XU Xiao-Mei,CHENG Qing-bing.Content determination of Ozagrel Sodium for injection by HPLC method[J].Journal of Anhui Heaith Vocational & Technical College,2013(5):84-85,79. |
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| Authors: | XU Xiao-Mei CHENG Qing-bing |
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| Institution: | 1.Anhui Provincial Hospital of traditional Chinese Medicine, Hefei 230031,Anhui 2.Hefei Municipal Food and drug administration and inspection, Hefei 238000,Anhui) |
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| Abstract: | Objective：To establish a method to determine the content of Ozagrel Sodium For injection by HPLC. Methods：Using the method of HPLC, with eighteen alkyl silane bonded silica as filler,Phosphate buffer solution （acetonitrile -0.25mol/L weigh 3.9G sodium dihydrogen phosphate, adding deionized water 1000ml dissolved, add 5ml of three triethylamine, pH value is adjusted with phosphoric acid to 3.0）（15 ： 85） as the mobile phase,The detection wavelength was 277nm, The flow rate was 1.Oral/rain. Result：ozagrel sodium in 4.09 p. g/ml - 16.36 μg/ml and the linear range, correlation coefficient r=0.9999 （ n = 5 ）, the average recovery rate was 99.5%（ RSD = 0.28%, n =9）. Conclusion：the method is accurate, reliable, and reproducible, which can be used as one of the methods for quality control of this preparation. |
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| Keywords: | Ozagrel Sodium For injection Ozagrel HPLC Content |
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