HPLC法同时测定复方阿莫西林氯唑西林钠胶囊的含量及有关物质  

Determination of Compound Amoxicillin and Cloxacillin Sodiam Capsules and Its Related Substances by HPLC

作　　者：戚燕[1] 杨庆云[1] 童元峰[1] 郝玲花[1] 吴松[1] 

机构地区：[1]中国医学科学院北京协和医学院药物研究所卫生部天然药物生物合成重点实验室,北京100050

出　　处：《中国药师》2009年第9期1174-1177,共4页China Pharmacist

基　　金：国家科技支撑计划课题(编号:2008BA155B00);卫生公益性行业科研专项经费(项目编号:200802038)

摘　　要：目的:建立同时测定阿莫西林氯唑西林钠胶囊的含量和有关物质的HPLC方法。方法:用C_(18)(150mm×4.6mm,5μm)色谱柱,以乙腈:0.02mol·L^(-1)磷酸盐缓冲液(pH5.0)为流动相进行梯度洗脱,流速1.0ml·min^(-1),检测波长230nm。结果:阿莫西林和氯唑西林均在0.10～0.60mg·ml^(-1)浓度范围内呈良好的线性关系。阿莫西林的平均回收率为99.4%,RSD=0.1%(n=9)。氯唑西林的平均回收率为99.4%,RSD=0.1%(n=9)。结论:方法可靠、简便、准确。可作为复方阿莫西林氯唑西林钠胶囊的含量和有关物质的质量控制。Objective： To establish a HPLC method for determination of compound amoxicillin and cloxacillin sodium capsules and its related substances. Method： The Kromasil C18 column（150mm×4.6mm,5μm） was used, the mobile phase was aeetonitrile - 0.02M potassium dihydrogen phosphate solution（ pH5. 0） gradient elution, the flow rate were 1.0ml· min^-1, the detection wavelength was 230nm. Result： The linear ranges of amoxcillin and cloxacillin both was 0.1 - 0.60mg· ml^-1, r = 0. 999 8 and r = 0. 999 9, the average recoveries （ n = 9） both were 99.4% with RSD both were 0. 1%. Conclusion： The method is reliable, convenient and accurate, it can be used for determination of compound amoxicillin and cloxacillin sodium capsules and its related substances.

关 键 词：阿莫西林 氯唑西林钠 含量测定 有关物质 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]