盐酸洛美沙星滴眼液的有关物质及其质量评价  

Measurement of related substances and quality evaluation of lomeflexacin hydrochloride eye drops

作　　者：宋诗文[1,2] 刘晓杰[1] 王雁凌[1] 马永付 赵怀清[1] 张鹏[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]齐齐哈尔医院第一附属医院,黑龙江齐齐哈尔161000 [3]宁夏康亚药业有限公司,宁夏银川750000

出　　处：《沈阳药科大学学报》2016年第11期854-860,893,共8页Journal of Shenyang Pharmaceutical University

摘　　要：目的 制备盐酸洛美沙星滴眼液的光降解杂质并建立其有关物质方法学,同时对不同厂家的滴眼液进行质量评价。方法 色谱柱采用Welch AQ-C18（250 mm×4.6 mm,5μm）,流动相为戊烷磺酸钠溶液-甲醇,梯度洗脱。检测波长：287 nm,柱温：35℃,流速：1.0 m L·min-1,进样量：20μL。按上述条件,对不同厂家滴眼液的有关物质进行检查。结果 对所制备杂质进行结构确证,为洛美沙星的氯代产物。在本文作者所建立的色谱条件下,盐酸洛美沙星滴眼液中洛美沙星、氯代洛美沙星与辅料峰之间分离度良好,在0.40～1.59 mg·L-1质量浓度内线性关系良好;r=0.999 7;平均回收率为100.1%,RSD为1.2%（n=9）。各厂家滴眼液有关物质均符合规定。结论 该方法可以用来控制该制剂的质量。8个厂家盐酸洛美沙星滴眼液的质量相对稳定。Objective To obtain the photodegradation products of lomefloxacin hydrochloride eye drops and establish a method for determination of related substances. To compare the quality of lomefloxacin hydrochloride eye drops from different manufacturers. Methods Using pentane sulfonate solution-methanol as gradient elution mobile phase at the flow rate of 1.0 mL.min-1, the separation was performed Welch AQ-C18 column（250 mm ×4.6 mm,5 μm）. Detection wavelength was set at 287 nm,and column temperature was set at 35 ℃. The injection volume was 20 μL. Measuring the related substances in lomefloxacin hydrochloride eye drops from different manufacturers according to the above conditions. Results The structure of impurity A was proved to be chlorinated product of lomefloxacin. The chromatographic conditions established in this paper showed good capacity in separating lomefloxacin peak and excipient peak. The linear range of calibration curve was 0. 40 - 1.59 mg. L - 1, r = 0. 999 7 and the average recovery was 100. 1% with 1.2% of RSD （n = 9 ）. The quality of all lomefloxacin eye drops from different manufacturers. Conclusions The method is sensitive, durability, and reproducible and can be used for quality control of lomefloxacin hydrochloride eye drops. The eye drops from 8 manufactures all meet criteria.

关 键 词：盐酸洛美沙星滴眼液 杂质制备 有关物质方法学 质量评价 

分 类 号：R917[医药卫生—药物分析学]