复方盐酸左氧氟沙星丁卡因滴眼液的制备及其质量控制

Preparation and Quality Control of Compound Levofloxacin Hydrochloride and Tetracaine Hydrochloride Eye Drop

目的:制备复方盐酸左氧氟沙星丁卡因滴眼液,并建立其质量控制方法。方法:选择盐酸左氧氟沙星及盐酸丁卡因为主药制备复方滴眼液,采用反相高效液相色谱法测定其中主药的含量;通过考察性状、可见异物、pH值、渗透压等指标初步确定其质量控制方法,并对其进行稳定性考察。结果:盐酸左氧氟沙星和盐酸丁卡因检测浓度的线性范围分别为15.06～90.36μg·mL-1(r=0.9998)、7.57～45.42μg·mL-(1r=0.9997),平均回收率分别为102.75%(RSD=1.31%)、99.95%(RSD=0.85%)。所得制剂为淡黄色澄明液体,可见异物符合2010年版《中国药典》(二部)附录IG眼用制剂项下的有关规定,pH在4.0～5.0之间,渗透压为0.285～0.310Osmol;样品在高温、高湿、光照条件下放置10d及室温下放置1个月,各项指标均无明显变化。结论:本制剂处方合理,制备工艺简单,稳定性好,含量测定方法简便、准确。

OBJECTIVE： To prepare Compound levofloxacin hydrochloride and tetracaine hydrochloride eye drop and to estab-lish the method of quality control. METHODS： Levofloxacin hydrochloride and tetracaine hydrochloride were used as main compo-nents for the preparation of Compound levofloxacin hydrochloride and tetracaine hydrochloride eye drop, and the contents of main components were determined by RP-HPLC. The method of quality control was established through investigating property, visible impurity, pH value and osmotic pressure, and the stability of samples was tested. RESULTS： The linear ranges of levofloxacin hy-drochloride and tetracaine hydrochloride were 15.06-90.36μg·mL^-1（r=0.999 8） and 7.57-45.42μg·mL^-1（r=0.999 7）. Aver- age recoveries were 102.75% （RSD=1.31% ） and 99.95% （RSD=0.85 % ）. The compound eye drop appeared as clear buff liquid, and visible impurity was in conformity with the related specification stated in Chinese Pharmacopeia （2010 edition） ; pH value of preparation ranged 4.0-5.0 and osmotic pressure was 0.285-0.310 Osmol. The preparation was stable under the circumstances of high temperature, high humidity and high light within 10 days or under room temperature for a month. CONCLUSIONS： The for- mula of the preparation is reasonable, and the preparation technology is simple and stable. The method of content determination is simple and accurate.