甲磺酸帕珠沙星凝胶的制备及含量测定

Preparation and determination of pazufloxacin mesylate gel

目的：制备甲磺酸帕珠沙星凝胶并建立其含量测定方法。方法：以卡波姆-940为基质制备凝胶，用紫外分光光度法在λ=247mm处测定甲磺酸帕珠沙星凝胶的含量。结果：甲磺酸帕珠沙星的pH值6．0—7．0，线性范围为2．0～16．0μg·mL^-1，平均回收率99．75％，RSD为0．41％。其它试验均符合凝胶剂的有关规定。结论：本制剂工艺简单，质量可控，性质稳定，有良好的临床使用价值。

Objective ：To prepare pazufloxacin mesylate gel and to establish a content determination method of the gel. Methods： Carbomer -940 was used to prepare pazufloxacin mesylate gel. The content of pazufloxacin mesylate gel was determined by UV spectrophotometry （λ=247nm）. Results： The pH value of pazufloxacin mesylate was 6. 0 -7.0. The hygiene examination was qualified. The linear range was 2.0 - 16.0μ g-mL^-1. The average recovery was 99.75%, RSD was 0.41%. Conclusion：The preparation technique is simple and reliable. The gel is stable in quality, and suitable for clinical application.