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目的 :建立定量参数校正因子用于五种喹诺酮药物含量测定的方法。方法 :采用HPLC法测定,用Phenomenex C18(150mm×4.6mm,5μm)、DIKMA C18(150mm×4.6mm,5μm)和Alltima(150mm×4.6mm,5μm)三根色谱柱,柱温25℃;流动相为0.2mol·L-1枸橼酸溶液-甲醇-乙腈(84:12:4);流速为1.0m L·min-1;检测波长为319nm。以氟罗沙星或洛美沙星为参比物的定量参数校正因子法计算样品含量。结果 :在三根不同的C18柱上相邻峰间的分离度均大于2.9,五种药物在25~250μg·m L-1线性关系良好,定量参数校正因子计算含量与法定方法测定的含量结果比较,经t检验,无显著性差异。结论 :本方法快速、准确,只需采用氟罗沙星或洛美沙星为对照品即可同时测定五种喹诺酮药物的含量。
OBJECTIVE: To establish a method for quantitative determination of five quinolone drugs by using quantitative parameter correction factor. METHODS: The HPLC method was used. Three columns with Phenomenex C18 (150mm × 4.6mm, 5μm), DIKMA C18 (150mm × 4.6mm, 5μm) and Alltima (150mm × 4.6mm, Was 0.2mol·L-1 citric acid solution-methanol-acetonitrile (84: 12: 4). The flow rate was 1.0m L · min-1. The detection wavelength was 319nm. The sample content was calculated using the quantitative parameter correction factor method with fleroxacin or lomefloxacin as reference. Results: The resolution of adjacent peaks on three different C18 columns was greater than 2.9. The linear relationships of five drugs at 25 ~ 250 μg · mL-1 were good. The calculated results of quantitative parameters correction factor were compared with those determined by the statutory method , By t test, no significant difference. Conclusion: The method is rapid and accurate. The content of five quinolone drugs can be determined simultaneously by using fleroxacin or lomefloxacin as reference substance.