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HPLC法测定羟基脲片的含量
引用本文:刘德胜,徐玉文,陈向明,云飞,栾海云,吕青志.HPLC法测定羟基脲片的含量[J].中国生化药物杂志,2010,31(3).
作者姓名:刘德胜  徐玉文  陈向明  云飞  栾海云  吕青志
作者单位:1. 滨州医学院,山东,烟台,264003
2. 山东省药品检验所,山东,济南,250101
基金项目:本研究为《中国药典》2010年版科研课题 
摘    要:目的建立HPLC法测定羟基脲片中羟基脲含量的方法。方法采用岛津VP C18柱(250 mm×4.6 mm,5μm);柱温:35℃;流动相:甲醇-水(5∶95);流速:0.5 mL/min;检测波长:214 nm;进样量:20μL。结果羟基脲主峰与辅料峰良好分离,羟基脲在50~150μg范围内与峰面积呈良好线性关系,r=0.999 5,方法的重复性良好(RSD=0.58%)。结论该法准确、简便、快速,适用于羟基脲片的质量控制。

关 键 词:羟基脲片  含量测定  高效液相色谱法

Determination of content in hydroxycarbamide tablets by HPLC
LIU De-sheng,XU Yu-wen,CHEN Xiang-ming,YUN Fei,LUAN Han-yun,LU Qing-zhi.Determination of content in hydroxycarbamide tablets by HPLC[J].Chinese Journal of Biochemical Pharmaceutics,2010,31(3).
Authors:LIU De-sheng  XU Yu-wen  CHEN Xiang-ming  YUN Fei  LUAN Han-yun  LU Qing-zhi
Abstract:Purpose To establish a HPLC method for the determination of the content hydroxycarbamide tablets by HPLC.Methods A Shimadzu VP-ODS C18 column(250 mm×4.6 mm,5 μm)with UV detection at 214 nm,and methanol-water(5∶95) as the mobile phase were used.The flow rate was 0.5 mL/min,and the temperature of the column was 35 ℃.Results An excellent separation was achieved for hydroxycarbamide and excipient and the calibration curve was liner in the range of 50-150 μg of hydroxycarbamide,r=0.999 5.The reproducibility and precision of the method were good(RSD=0.58%).Conclusion This method was accurate,simple,quick and effective for the determination of the content in hydroxycarbamide tablets.It was also suitable for the quality control for hydroxycarbamide tablets.
Keywords:hydroxycarbamide tablets  assay  HPLC
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