[关键词]
[摘要]
目的 建立HPLC法测定加替沙星有关物质。方法 采用HPLC法,色谱柱为Agilent HC-C18(250 mm × 4.6 mm,5 μm),流动相为三乙胺磷酸溶液 [三乙胺溶液(1→100),用磷酸调节pH值至4.3]-乙腈(87:13),检测波长为325 nm,柱温为30 ℃。结果 加替沙星和9个已知杂质均能达到基线分离,样品中各杂质及主峰的分离度和检测灵敏度均满足有关物质的测定要求。结论 方法灵敏、准确,专属性强,可有效控制产品质量。
[Key word]
[Abstract]
Objective To establish a method for the determination of related substances in gatifloxacin by HPLC. Methods The separation was performed on a Agilent HC-C18 column (250 mm × 4.6 mm, 5 μm). using triethylamine-phosphoric acid solution [triethylamine solution (1→100), adjusted to pH 4.3 by phosphoric acid]-acetonitrile (87:13) as mobile phase. The column temperature was 30 ℃ and detective wavelength was 225 nm. Results The resolutions between gatifloxacin and its nine known impurities could meet the requirement. The sensitivity of the method was acceptable. Conclusion The method is sensitive, accurate, and specific, and can be used for the quality control of product effectively.
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[基金项目]
全球基金结核病整合项目卫生系统加强部分:药品质量标准提高课题(GF2012-34,GF2012-35,GF2012-36)