HPLC法测定氟罗沙星含量的稳定性研究

• 作 者: 顾晔 杜渊 金新
• 机 构: 无锡市产品质量监督检验中心,无锡市第三人民医院,江苏无锡福祈制药有限公司,
• 出 处: 轻工科技
• 发表日期: 2012年09期
• 关键词: HPLC 三乙胺磷酸溶液 氟罗沙星 杂质峰 含量测定 高效液相色谱法 流动相 线性关系 三乙胺 色谱柱

采用高效液相色谱法,色谱柱选用C18(250×4.6mm 5μ),以三乙胺磷酸溶液(取三乙胺5ml和磷酸7ml,加水至1000ml)-乙腈(87:13)为流动相,流速为1.0ml/min,检测波长为286nm。结果表明:当流动相的pH为4.6时,氟罗沙星的主峰不受相邻杂质影响,含量稳定。氟罗沙星在0.010013~0.10013 mg/ml范围内线性关系良好,R=0.9999;平均回收率为99.32%;检测限为0.002ng。pH改变后,氟罗沙星含量测定时排除了相邻杂质峰对主峰的干挠,主峰面积稳定,专属性好。

The mobile phase consisted of C18 (250 × 4.6mm 5μ), triethylamine phosphoric acid (5ml triethylamine and phosphoric acid 7ml, water to 1000ml) - acetonitrile (87:13) The flow rate was 1.0 ml / min and the detection wavelength was 286 nm. The results show that the main peak of fleroxacin is not affected by the adjacent impurities and the content is stable when the mobile phase pH is 4.6. Fleroxacin showed good linearity in the range of 0.010013 ~ 0.10013 mg / ml with R = 0.9999; the average recovery was 99.32%. The detection limit was 0.002ng. After the pH was changed, the determination of fleroxacin excluded the interference of the adjacent impurity peak on the main peak, the main peak area was stable and the specificity was good.