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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,5μm),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。
Objective To establish a HPLC method for the determination of gatifloxacin related substances. Methods The HPLC method was performed on an Agilent HC-C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of triethylamine phosphate solution (1 → 100 in triethylamine) and the pH was adjusted to 4.3 with phosphoric acid Acetonitrile (87:13). The detection wavelength was 325 nm and the column temperature was 30 ℃. Results Gatifloxacin and nine known impurities were able to achieve baseline separation. The separation and detection sensitivity of the impurities and main peaks in the sample all met the requirements of determination of related substances. Conclusion The method is sensitive, accurate and specific, which can effectively control product quality.