甲磺酸帕珠沙星凝胶剂的制备与质量控制

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 C18（250mm×4．6mm，5um）；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：1．0ml·min^-1；检测波长：240nm；进样量：20ul。结果：甲磺酸帕珠沙星在10．54～52．7ug·ml^-1范围内有良好的线性关系，r=0．9993，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。

Preparation and Quality Control of Pazufloxacine Mesylate Gel

Objective： To establish a method for preparation and quality control of pazufloxacine mesylate gel. Method： The carbomer was used as stroma to prepare pazufloxacine mesylate gel. The content of pazufloxacine mesylate was determined by HPLC. The Diamonsil Cis column （ 250mm × 4.6mm,5 um） was used, acetonitrile-the aqueous solution （containing 0.5 % phosphoric acid and 1% triethylamine） （30：70 ） was used as mobile phase with a flow rate of 1.0 ml·min^-1 , the detect wavelength was at 240nm, and injection volume was 20ul. Result： A good linearity of pazufloxacine mesylate was obtained within the range of 10.54 -52.70ug. ml^-1 （ r = 0. 999 3 ）. The average recovery of pazufloxacine mesylate was 99.67% （ RSD = 1.79% ）. Conclusion： The preparation proeess is simple and available. The method can be used for quality control of pazufloxacine mesylate gel.