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HPLC法测定帕瑞昔布钠中有关物质的方法研究

2016-03-03 中国测试聂忠莉1, 郭兆元2, 萧茂玲1, 王晓玲3, 张 勇3, 郭 瑞3, 叶 丁3 分享
 
摘  要:建立以高效液相色谱法(HPLC)测定帕瑞昔布钠中有关物质的方法。色谱柱为C18柱(4.6 mm×250 mm×5 μm),乙腈-0.01 mol/L磷酸氢二钠溶液(用磷酸调节pH值至3.0)(47∶53,ν∶ν)为流动相,检测波长为215 nm,柱温40 ℃。经过优化色谱条件后,帕瑞昔布钠峰与6个已知杂质峰均可达到基线分离,样品主峰及各杂质的色谱峰的灵敏度和分离度均满足测定要求。采用HPLC法测定帕瑞昔布钠中的有关物质,专属性强,方法灵敏度高,结果准确可靠。
关键词:HPLC法;帕瑞昔布钠;杂质;代地昔布
文献标志码:A       文章编号:1674-5124(2015)12-0054-05
Research on HPLC method for related substances in parecoxib sodium
NIE Zhongli1, GUO Zhaoyuan2, XIAO Maoling1, WANG Xiaoling3, ZHANG Yong3, GUO Rui3, YE Ding3
(1. School of Pharmacy and Bioengineering,Chengdu University,Chengdu 610106,China;
2. Sichuan Industrial Institute of Antibiotics,Chengdu University,Chengdu 610106,China;
3. Chengdu Climb Pharmaceutical Technology Co.,Ltd.,Chengdu 610041,China)
Abstract: To determine related substances in parecoxib sodium with high performance liquid chromatograph(HPLC). C18 column has been used as filler (4.6 mm×250 mm×5 μm) and acetonitrile -0.01 mol/L ammonium dihydrogen phosphate (adjusted to pH 3.0 with phosphoric acid) (47∶53,ν∶ν) as mobile phase. The detection wavelength was set at 215 nm and the column temperature 40 ℃. After the optimization of chromatographic conditions, the parecoxib sodium peak and 6 known impurity peaks meet the requirement of baseline separation. The sensitivity and resolution of the main peak of the samples and the chromatographic peak of all the impurities are both acceptable. The HPLC method is specific and reliable.
Keywords: HPLC method; parecoxib sodium; impurities; valdecoxib
 
 
 
 
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