氟康唑莫西沙星眼用即型凝胶的制备及质量控制

目的:制备氟康唑莫西沙星眼用即型凝胶并建立其质量控制方法。方法:试验不同浓度的泊洛沙姆为基质制备凝胶,采用高效液相色谱法测定氟康唑、莫西沙星和羟苯乙酯的含量。色谱柱为依利特Hypersil ODS,流动相为三乙胺缓冲液(pH3.3)-甲醇(61∶39),流速为1.0 mL.min-1,柱温为30℃,检测波长为260 nm。结果:以15.5%泊洛沙姆407为基质制备凝胶,其胶凝温度为32℃。氟康唑、莫西沙星、羟苯乙酯的检测浓度线性范围分别为100～600(r=0.999 9)、100～600(r=0.999 9)、10～60μg.mL-(1r=0.999 8),平均回收率分别为99.75%、99.89%、100.10%,RSD分别为1.26%、1.08%、1.72%。结论:该制剂处方设计合理,制备方法简单,质量可控。

Preparation and Quality Control of Fluconazole/Moxifloxacin in Situ Forming Eye Gel

OBJECTIVE: To prepare Fluconazole/moxifloxacin in situ forming eye gel,and to establish a quality control method for it.METHODS: The gel was prepared with different concentrations of poloxamer 407 as base,and the contents of fluconazole,moxifolxaein and ethylparaben were determined by HPLC.The determination was performed on Elite Hypersil ODS column with mobile phase consisted of triethylamine buffer solution(pH 3.3)-methanol(61 ∶ 39) at the flow rate of 1.0 mL·min-1.The column temperature was 30 ℃ and the detection wavelength was set at 260 nm.RESULTS: The gel was prepared using 15.5% poloxamer 407 as base and its gel-forming temperature was 32 ℃.The linear ranges were 100～600 μg·mL-1 for fluconazole(r=0.999 9),100～600 μg·mL-1 for moxifolxacin(r=0.999 9) and 10～60 μg·mL-1 for ethylparaben(r=0.999 8).Moreover,their average recovery rates were 99.75%(RSD=1.26%),99.89%(RSD=1.08%) and 100.10%(RSD=1.72%).CONCLUSION: The gel is reasonable in design,simple in preparation method and reliable in quality control.