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目的 :建立甲磺酸帕珠沙星的RP HPLC含量测定及有关物质检测方法。方法 :采用C18柱 (5 μm ,4 .6mm× 2 5 0mm) ,流动相为乙腈 磷酸三乙胺水溶液 (含 0 .5 %磷酸 ,1%三乙胺 ) (5 2∶4 8) ,检测波长为 2 5 4nm。结果 :甲磺酸帕珠沙星在 1.0～ 2 0 0 μg·mL-1浓度范围内 ,峰面积与浓度呈良好线性关系 (r =0 .9997) ,平均回收率为(99.3± 0 .5 6 ) %。结论 :本法简便 ,专属性及重现性好 ,可用于测定甲磺酸帕珠沙星含量及有关物质。
Objective: To establish a RP HPLC method for the determination of pazufloxacin mesylate and its related substances. Methods: C18 column (5 μm, 4.6 mm × 250 mm) was used as the mobile phase. The mobile phase consisted of acetonitrile and triethylamine (0.5% phosphoric acid, 1% triethylamine) Wavelength of 254nm. Results: Pazufloxacin mesylate showed a good linearity (r = 0.9997) with a peak area of 1.0-2.00 μg · mL-1 and an average recovery of (99.3 ± 0.5) 6)%. Conclusion: This method is simple, specific and reproducible, and can be used to determine pazufloxacin mesylate content and related substances.