高效液相色谱法测定复方锌布颗粒中布洛芬的溶出度  

HPLC determination of the dissolution of ibuprofen in compound Zinc gluconate and ibuprofen granules

作　　者：兰文 李昌亮 

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12期1314-1317,共4页Central South Pharmacy

基　　金：国家药典会药品标准提高研究课题(No.2013429)

摘　　要：目的建立高效液相色谱方法测定复方锌布颗粒中布洛芬的溶出度。方法按照中国药典2010年版二部溶出度测定方法第二法,以磷酸氢二钠-枸橼酸缓冲液（p H=5.5±0.02）900 m L为溶出介质,转速为50 r·min-1,采用HPLC法测定布洛芬的浓度。HPLC法中选用Agilent HC C18柱（250 mm×4.6 mm,5μm）,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1000m L）（70：30）为流动相,检测波长为263 nm。结果该方法线性范围为16.29-814.5μg·m L-1（r=1.000）,平均回收率为100.5%,RSD为0.4%（n=3）。结论本法简便、准确,能较好的区分不同生产工艺产品溶出行为的差异,在一定程度上反应了该产品的内在质量。Objective To establish an HPLC method to determine the dissolution of ibuprofen in compound Zinc gluconate and ibuprofen granules. Methods Pharmacopoeia of the People＇s Republic of China（2010） Volume Ⅱ, Appendix XC Ⅱ was referred to, 900 m L disodium hydrogen phosphate-citrate buffer（pH = 5.5±0.02） was used as the dissolution medium and apparatus at 50 r·min- 1. We used HPLC method to determine the dissolution of ibuprofen. Agilent HC C18（250 mm×4.6 mm, 5 μm） was used. Acetonitrile-ammonium dihydrogen phosphate solution（dissolving 2.0 g ammonium dihydrogen phosphate and 1 m L phosphoric acid in 1000 m L water）（70 ：30） was used as the mobile phase and the detection wavelength was 263 nm. Results The linear range was 16.29- 814.5 μg·m L- 1（ r = 1.000）. The average recovery was 100.5% with RSD of 0.4%（ n = 3）. Conclusion This method is simple and accurate, and can be used to distinguish the production process, and reflect the intrinsic quality of the product.

关 键 词：复方锌布颗粒 布洛芬 溶出度 高效液相色谱法 

分 类 号：R94[医药卫生—药剂学]