摘 要 目的：建立鹽酸左旋多巴甲酯片中有關(guān)物質(zhì)的高效液相色譜測定方法。方法：色譜柱采用WondailTM C18柱(4.6 mm×250 mm，5μm)；流動相：0.05mol/L磷酸二氫鉀（磷酸調(diào)pH=3.5）：甲醇=80:20；流速：1.0 ml/min；檢測波長：280nm；柱溫：40℃；進樣量20μl。結(jié)果：有關(guān)物質(zhì)各雜質(zhì)峰與主峰之間分離良好，最低檢測限為1.25ng，最低定量限為4.13ng。結(jié)論：該方法簡便，快速，結(jié)果準確，分離效果好，能作為鹽酸左旋多巴甲酯片有關(guān)物質(zhì)的測定方法。

關(guān)鍵詞 鹽酸左旋多巴甲酯片；有關(guān)物質(zhì)；高效液相色譜法

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