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目的:建立甲磺酸帕珠沙星凝胶剂的制备方法和质量标准。方法:以卡波姆为凝胶基质,制备甲磺酸帕珠沙星凝胶。采用高效液相色谱法测定凝胶中甲磺酸帕珠沙星的含量,色谱柱:Diamonsil C_(18)(250mm×4.6mm,5μm);流动相:乙腈-磷酸三乙胺水溶液(含0.5%磷酸,1%三乙胺)(30:70);流速:1.0 ml·min~(-1);检测波长:240nm;进样量:20μl。结果:甲磺酸帕珠沙星在10.54～52.7μg·ml~(-1)范围内有良好的线性关系,r=0.999 3,平均回收率为99.67%,RSD=1.79%。结论:该制备工艺简单、易行,质量控制方法切实可行。
Objective: To establish the preparation method and quality standard of pazufloxacin mesylate gel. METHODS: Pazufloxacin mesylate gel was prepared with carbomer as the gel matrix. The content of pazufloxacin mesylate in the gel was determined by HPLC. Diamonsil C_ (18) (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of acetonitrile-triethanolamine % Phosphoric acid, 1% triethylamine) (30:70); flow rate: 1.0 ml · min -1; detection wavelength: 240 nm; injection volume: 20 μl. Results: Pazufloxacin had a good linear relationship in the range of 10.54-52.7μg · ml -1, r = 0.999 3, the average recovery was 99.67% and RSD was 1.79%. Conclusion: The preparation process is simple and easy to implement, and the quality control method is feasible.