hplc法测定盐酸左旋多巴甲酯片有关物质.doc
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hplc法测定盐酸左旋多巴甲酯片有关物质,hplc法测定盐酸左旋多巴甲酯片有关物质摘 要 目的:建立盐酸左旋多巴甲酯片中有关物质的高效液相色谱测定方法。方法:色谱柱采用wondailtm c18柱(4.6 mm×250 mm,5μm);流动相:0.05mol/l磷酸二氢钾(磷酸调ph=3.5):甲醇=80:20;流速:1.0 ml/min;检测波长:280nm...
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HPLC法测定盐酸左旋多巴甲酯片有关物质
摘 要 目的:建立盐酸左旋多巴甲酯片中有关物质的高效液相色谱测定方法。方法:色谱柱采用WondailTM C18柱(4.6 mm×250 mm,5μm);流动相:0.05mol/L磷酸二氢钾(磷酸调pH=3.5):甲醇=80:20;流速:1.0 ml/min;检测波长:280nm;柱温:40℃;进样量20μl。结果:有关物质各杂质峰与主峰之间分离良好,最低检测限为1.25ng,最低定量限为4.13ng。结论:该方法简便,快速,结果准确,分离效果好,能作为盐酸左旋多巴甲酯片有关物质的测定方法。
关键词 盐酸左旋多巴甲酯片;有关物质;高效液相色谱法
Determination of related substances in L-dopa methyl ester hydrochloride tablet by HPLC
ABSTRACT Objective:To establish an HPLC method for the determination of related substances in L-dopa methyl ester hydrochloride.Methods:The WondailTM C18 column (4.6 mm×250 mm,5 μm) was used, the mobile phase was 0.05 mol/L potassium dihydrogen phosphate(adjust pH to 3.5 by phosphoric acid) — methanol = (80 ∶20) ,the flow was 1.0 mL /min.The detection wavelength was 280 nm,the column temperature was 40 ℃ and the injection volume was 20 μL.Results: Related substances was separated well,and LOD was 1.25 ng,LOQ was 4.13ng.Conclusion: The method is simple, accurate and good resolution. It can provided a new and reliable means of the quality control of determination of related substances in L-dopa methyl ester hydrochloride tablet.
Key words: L-dopa methyl ester hydrochloride tablet; Related substance;HPLC