HPLC法测定己二烯雌酚片的有关物质

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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 establish a HPLC method for the determination of related substances of dienestrol tablets. Methods: The mobile phase was Hypersil C18 column (250 mm × 4.6 mm, 5 μm) with methanol-acetonitrile (76:24) as the mobile phase at the flow rate of 0.8 ml · min-1 and the detection wavelength of 229 nm. Results: Diethylstilbestrol was completely separated from related substances under the selected chromatographic conditions with a minimum detection limit of 2 ng. Conclusion: The method is simple, accurate, specific, sensitive and can be used for the determination of related substances in dienestrol tablets.
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