复方阿莫西林纳米乳的高效液相色谱分析及有效期研究  

Study on Establishment of High Performance Liquid Chromatography Analytical Method for Determination of Compound Amoxicillin and Levofloxacin Hydrochloride Nanoemulsion and Its Expiration Date

作　　者：杨雪峰[1,2] 宁红梅[1] 孙红武[2,3] 欧阳五庆[2] 

机构地区：[1]河南科技学院动物科学学院,河南新乡453003 [2]西北农林科技大学动物医学院,陕西杨凌712100 [3]第三军医大学药学院,重庆400038

出　　处：《湖北农业科学》2012年第2期385-388,共4页Hubei Agricultural Sciences

基　　金：国家科技支撑计划奶业发展重大关键技术研究与示范(2006BAD04A11)

摘　　要：利用高效液相色谱仪建立测定复方阿莫西林纳米乳(AMX-LH-NE)中阿莫西林(AMX)和盐酸左氧氟沙星(LH)两种主药含量的高效液相色谱(HPLC)分析方法,并确定该药物的有效期。结果表明,AMX和LH分别在0.5～50μg/mL和5～60μg/mL浓度范围内线性关系良好;平均回收率为(99.27±1.26)%和(99.65±1.51)%,相对标准偏差(RSD)为1.27%和1.52%;平均保留时间为(10.22±0.13)min和(7.15±0.13)min;日内精密度RSD为1.56%和1.75%,日间精密度RSD为2.46%和2.62%。AMX-LH-NE的有效期为20个月。建立的HPLC分析方法专属性好,回收率、重复性和精密度高,可用于AMX-LH-NE制剂的主药含量测定及其质量控制。High performance liquid chromatography（HPLC） method was established for the determination of Amoxicillin（AMX） and Levofloxacin hydrochloride（LH） in the compound Amoxicillin and Levofloxacin hydrochloride nanoemulsion（AMX-LH-NE）,and its expiration date by the high performance liquid chromatograph was detected.The results showed that two good linearity were respectively obtained by AMX in the range of 0.5～50 μg/mL and by LH in the range of 5～60 μg/mL,and the average recovery,relative standard deviation（RSD）,average retention time,RSD of the with-in-day precision,RSD of the day-to-day precision of AMX and LH were（99.27±1.26）% and（99.65±1.51）%,1.27% and 1.52%,（10.22±0.13） min and（7.15±0.13） min,1.56% and 1.75%,2.46% and 2.62%,respectively.The expiration date was 20 months.The two analytical methods of HPLC possessed good specificity,high recovery rate,repetitiveness and precision,it could be used to determine and control the principal agents in the preparation of AMX-LH-NE.

关 键 词：阿莫西林 纳米乳 盐酸左氧氟沙星 高效液相色谱法 有效期 

分 类 号：S859.53[农业科学—临床兽医学]