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目的:反相高效液相色谱法测定甲磺酸帕珠沙星原料含量及其有关物质。方法:采用HypersilC18(5μm,4.6mm×250mm)色谱柱,以0.1%磷酸(加0.0805g磷酸氢二钾):乙腈(85:15)为流动相,流速1.0mL.min,柱温30℃,于243nm波长处测定甲磺酸帕珠沙星含量及有关物质。40±2℃放置6个月、25±2℃放置12个月考察质量稳定性。结果:1.0-500μg/mL内峰面积与浓度线性关系良好。样品溶液室温放置24小时稳定,RSD<1.0%。甲磺酸帕珠沙星保留时间为7.012分钟,与有关物质分离度>1.5。3批原料含量平均值为99.8%,有关物质含量<1.0%。加速试验及长期放置质量稳定。结论乏RP-HPLC法测定甲磺酸帕珠沙星原料含量及其有关物质简便,结果可靠,可用于甲磺酸帕珠沙星原料及其制剂的质量控制。
Objective: To determine the content of pazufloxacin mesylate and its related substances by reversed-phase high performance liquid chromatography. Methods: The mobile phase consisted of Hypersil C18 (5μm, 4.6mm × 250mm), 0.1% phosphoric acid (0.0805g dipotassium hydrogenphosphate): acetonitrile (85:15) Determination of pazufloxacin mesylate at 243nm wavelength and related substances. 40 ± 2 ℃ for 6 months, 25 ± 2 ℃ for 12 months to investigate the quality of stability. Results: The peak area of 1.0-500μg / mL had a good linear relationship with the concentration. The sample solution was stable for 24 hours at room temperature with RSD <1.0%. Pazufloxacin mesylate retention time of 7.012 minutes, with the relevant material separation> 1.5.3 batch average content of raw materials was 99.8%, the relevant substance content <1.0%. Accelerated testing and long-term placement of quality and stability. Conclusion The RP-HPLC method for the determination of pazufloxacin mesylate content and related substances is simple and reliable, and can be used for the quality control of pazufloxacin mesylate raw materials and their preparations.