甲硝唑氧氟沙星滴鼻液的制备与质量控制

Preparation and Quality Control of Metronidazole Ofloxacin Nasal Drops

目的:制备甲硝唑氧氟沙星滴鼻液并建立其质量控制方法。方法:以甲硝唑和氧氟沙星为主药制备滴鼻液;采用双波长分光光度法测定含量,其中甲硝唑测定波长为275.8、301.7nm,氧氟沙星测定波长为293.4、252.7nm。结果:所制滴鼻液鉴别等均符合规定;甲硝唑、氧氟沙星检测浓度的线性范围分别为4.008～20.040、2.028～10.140μg·mL-1(r均为0.9999);平均加样回收率分别为99.93%(RSD=0.25%)、100.15%(RSD=0.43%)(n=6)。结论:该制剂制备工艺简单、可行,质量控制方法可靠、简便。

OBJECTIVE： To prepare Metronidazole ofloxacin nasal drops and to establish quality control method of it. METHODS： Metronidazole ofloxacin nasal drops were prepared using metronidazole and ofloxacin as main components. The contents of metronidazole and ofloxacin were determined by double wavelength spectrophotometry. The detection wavelengths were set at 275.8 nm and 301.7 nm for metronidazole, and 293.4 nm and 252.7 nm for ofloxacin. RESULTS： The qualitative identification of prepared nasal drops was in line with the requirement. The linear ranges of metronidazole and ofloxacin were from 4.008 to 20.040 μg. mL-1 and 2.028 to 10.140 μg·mL-1 （r=0.999 9）. The average recoveries were 99.93% （RSD=0.25%, n=6） and 100.15% （RSD= 0.43%, n=6）. CONCLUSION： Preparation technology is simple and feasible. The quality control method is reliable and simple.