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RP-HPLC法测定氢溴酸西酞普兰原料含量及有关物质 被引量:6

Determination of the Content of Citalopram Hydrobromide and Its Related Substances by RP-HPLC
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摘要 研究建立了高效液相色谱法测定氢溴酸西酞普兰原料药中有关物质和含量,采用色谱柱为Zorbax SB-C18 250×4.6 mm,5μm,流动相为甲醇∶0.1mol/L醋酸铵=60∶40(0.1 mol/L醋酸铵液加三乙胺0.1%,用醋酸调pH至5.0),紫外检测波长240 nm,流速1.0mL/min,柱温25℃,其线性范围在0.05~500μg/mL呈良好线性关系,氢溴酸西酞普兰与各中间体的分离度均大于1.5,本法简便、快速,重复性好。 The HPLC method for the determination of Citalopram Hydrobromide and its related substanceswas developed. The column: Zorbax SB-C18 250 × 4.6 mm, 5 μ m. The mobile phase:methanol:0.1mol/L ammonium acetate=60:40 (0.1% triethylamine, adjusting pH=5.0 by adding acetic acid). The flow rate: 1.0ml/min. The column temperature:25 ℃. The detection wavelength:240nm. The linear range of Citalopram Hydrobromide was 0.05 -500 μ g/ml, r=-0.9999, Citalopram Hydrobromide and its related substances could be completely separated. The proposed HPLC method is convenient, accurate and reproducible.
作者 魏君 谢剑炜
出处 《现代科学仪器》 2006年第3期59-60,共2页 Modern Scientific Instruments
关键词 氢溴酸西酞普兰 有关物质 高效液相色谱法 Citalopram hydrobromide related substances RP-HPLC
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  • 1ZHOU Hai-jun(周海均).Iternational Conference on Harmonidation of Technical Requirements for Registration of Pharmaceuticals for Human Use,Quality Section(ICH药品注册的国际技术要求,质量部分),Beijing(北京):People's Medical Publishing House(人民卫生出版社),2000.87
  • 2GhP (中国药典),2005.VolⅡ (二部):Appendix (附录) VD.28

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