高效液相色谱法测定复方锌布颗粒中马来酸氯苯那敏和布洛芬的含量与有关物质  

RP-HPLC determination of the content and related substances of chlorphenamine maleate and ibuprofen in compound zinc gluconate and ibuprofen granules

作　　者：兰文 李昌亮 黄海 

机构地区：[1]湖南省食品药品检验研究院,长沙410001

出　　处：《中南药学》2015年第9期970-973,共4页Central South Pharmacy

基　　金：国家药品标准提高研究课题(No.2013429)

摘　　要：目的采用高效液相色谱法同时测定复方锌布颗粒中马来酸氯苯那敏及布洛芬的有关物质与含量。方法采用C18柱,以乙腈-磷酸二氢铵溶液（取磷酸二氢铵2.0 g,加水适量使溶解,加磷酸1 m L,用水稀释至1000 m L）（10：90）为流动相A,乙腈为流动相B,流速为1.0 m L·min-1,梯度洗脱;检测波长262 nm。结果在该色谱条件下,杂质峰与主峰均能有效分离,马来酸氯苯那敏与布洛芬的线性范围分别为0.988-49.4μg·m L-1（r=1）及72.435-3621.75μg·m L-1（r=0.9998）,平均回收率分别在100.4%-101.1%及99.7%-100.4%。结论本法简便、准确,专属性强,有助于更好地控制本品的质量。Objective To establish an HPLC method to determine the related substances and the content of chlorphenamine maleate and ibuprofen in compound zinc gluconate and ibuprofen granules. Methods The separation was performed on a C18 column, and acetonitrile-ammonium dihydrogen phosphate solution（dissolving 2.0 g ammonium dihydrogen phosphate and 1 m L phosphoric acid in 1000 m L water）（10 ：90） as mobile phase A, acetonitrile as mobile phase B. The flow rate was 1.0 m L·min- 1, and linear gradient elution was used. The detection wavelength was 262 nm. Results Chlorphenamine maleate, ibuprofen and their related substances could be separated well under chromatographic conditions. The linear range was 0.988- 49.4 μg·m L- 1 for chlorphenamine maleate and 72.435-3621.75 μg·m L- 1 for ibuprofen. The average recoveries were 100.4%- 101.1% and 99.7%- 100.4%, respectively. Conclusion The method is simple, rapid, accurate, and can be used for the quality control of compound zinc gluconate and ibuprofen granules.

关 键 词：复方锌布颗粒 马来酸氯苯那敏 布洛芬 有关物质 含量测定 

分 类 号：R917[医药卫生—药物分析学]