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HPLC法测定己二烯雌酚片的有关物质

Determination of Related Substances in Dienestrol Tablets by HPLC
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摘要 目的:建立高效液相色谱法测定己二烯雌酚片的有关物质。方法:采用Hypersil C18色谱柱(250 mm×4.6 mm,5μm),甲醇-乙腈(76∶24)为流动相,流速:0.8 ml·min-1,检测波长:229 nm,进样量:10μl。结果:在选定的色谱条件下,己二烯雌酚与有关物质分离完全,最低检测限为2 ng。结论:该方法简便、准确、专属性好、灵敏度高,可用于己二烯雌酚片的有关物质测定。 Objective: To determine the related substances in dienestrol tablets by HPLC. Methods: The separation was performed on a C18 column (250 mm×4.6mm,5μm). The mobile phase consisted of methanol-acetonitrile (76:24), the flow rate was set at 0.8 ml·min-1 with the detection wayelength at 229 nm, and the sample size was 10 μl. Results: Under the established chromatographic conditions, the related substances and dienestrol were separated completely. The limit of detection was 2 ng. Conclusion: The method is simple, accurate, specific and sensitive in the determination of related substances in dienestrot tablets.
作者 海川 何胜利
出处 《中国药师》 CAS 2014年第2期341-343,共3页 China Pharmacist
关键词 己二烯雌酚片 有关物质 高效液相色谱法 Dienestrol tablets Related substances HPLC
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