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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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HPLC法测定左旋多巴的有关物质

Determination of related substances of levodopa by HPLC

分类号:
出版年·卷·期(页码):2014,34 (3):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立RP-HPLC测定左旋多巴有关物质的方法。方法:采用Welch XtimateTM C18色谱柱(250 mm×4.6 mm,5 μm),以甲醇-0.05 mol·L-1磷酸二氢钠缓冲液(pH 3.0)为流动相进行梯度洗脱,柱温30 ℃,流速1.0 mL·min-1,检测波长280 nm。结果:左旋多巴与各已知杂质及强制破坏产生的降解产物均分离良好,(2S)-2-氨基-3-(2,4,5-三羟基苯基)丙氨酸、左旋多巴、L-酪氨酸、3-甲氧基多巴、二甲氧基多巴和二甲氧基多巴酰化物浓度分别在0.2020~10.10 μg·mL-1r=0.9999)、0.1017~10.07 μg·mL-1r=1.000)、0.1046~10.46 μg·mL-1r=1.000)、0.08552~8.552 μg·mL-1r=0.9999)、0.09979~9.979 μg·mL-1r=1.000)和 0.09537~9.537 μg·mL-1r=1.000)范围内与峰面积呈良好的线性关系。已知杂质的平均回收率分别为100.4%、100.9%、99.8%、99.1%和99.1%,RSD依次为4.1%、4.5%、4.3%、3.9%和3.5%(n=9);上述化合物精密度试验RSD分别为1.7%、0.37%、0.56%、1.4%、0.39%和1.2%(n=6)。结论:本方法专属性强、准确、灵敏,可用于左旋多巴的有关物质检测和质量控制。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish an HPLC method for the determination of related substances of levodopa. Methods: The determination was performed on a Welch XtimateTM C18 column (250 mm×4.6 mm,5 μm),with a mobile phase consisting of a mixture of methanol and 0.05 mol·L-1 sodium dihydrogen phosphate buffer (pH 3.0) by gradient elution.The column temperature was set at 30 ℃ with a flow rate of 1.0 mL·min-1,and the detective wavelength was 280 nm. Results: The known impurities and degraded products by forced destruction were completely separated from levodopa.The calibration curves for (2S)-2-amino-3-(2,4,5-trihydroxyphenyl) propanoic acid, levodopa,L-tyrosine,3-methoxytyrosine,veratrylglycine and veratrylglycine acylate revealed good linearities over the ranges of 0.2020-10.10 μg·mL-1 (r=0.9999),0.1017-10.07 μg·mL-1 (r=1.000),0.1046-10.46 μg·mL-1 (r=1.000),0.08552-8.552 μg·mL-1 (r=0.9999),0.09979-9.979 μg·mL-1 (r=1.000) and 0.09537-9.537 μg·mL-1 (r=1.000),respectively.The recoveries of the impurities were 100.4% with RSD of 4.1%,100.9% with RSD of 4.5%,99.8% with RSD of 4.3%,99.1% with RSD of 3.9% and 99.1% with RSD of 3.5%,respectively.The precision of the above compounds were 1.7%,0.37%,0.56%,1.4%,0.39% and 1.2%,successively. Conclusion: The method is specific,accurate and sensitive,which can be used for the test of the related substances of levodopa and quality control.

-----参考文献:---------------------------------------------------------------------------------------

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