国产盐酸左氧氟沙星滴眼液杂质谱分析

Analysis of Impurity Spectrum of Domestic Levofloxacin Hydrochloride Eye Drops

目的优化盐酸左氧氟沙星滴眼液现行标准中有关物质的测定方法,并对国产盐酸左氧氟沙星滴眼液样品的杂质谱进行分析,从有关物质方面对质量进行评价。方法采用优化的HPLC方法对杂质进行定量分析,采用HPLC-MS分析未知杂质的归属与来源。结果定量分析表明65批样品单个最大杂质在0.2%以下,总杂质在0.37%以下,最主要的杂质为杂质E(去甲基物),来源为原料带入。结论国产盐酸左氧氟沙星滴眼液整体杂质控制水平良好,符合药典及现行标准相关要求。

Objective To optimize the assay method of related substances of domestic levofloxacin hydrochloride eye drops described in the current standard, analyze impurity spectrum and evaluate the quality from the aspect of related substances. Methods The optimized method of HPLC was used for the quantitative analysis of impurities. The source of unknown impurities was researched with HPLC-MS. Results The quantitative analysis indicated the content of maximum single impurity was below 0. 2 % , the total impurity was below 0. 37%. The primary impurity was impurity E （demethylation compound） from raw materials. Conclusion Overall, the impurities in domestic levofloxaein hydrochloride eye drops were well controlled and met requirements of the Chinese Pharmacopeia and the current standard.