HPLC法测定盐酸氨溴索口腔崩解片的含量  

Determination of Content of Ambroxol Hydrochloride Orally Disintegrating Tablets by HPLC

作　　者：刘天扬[1] 

机构地区：[1]黑龙江省药品检验所

出　　处：《黑龙江医药》2008年第5期3-4,共2页Heilongjiang Medicine journal

摘　　要：目的:建立高效液相色谱法测定盐酸氨溴索口腔崩解片的含量。方法:采用SHIMADAZUC_(18)色谱柱(4.6mm×150mm,5μm),流动相为甲醇-醋酸盐缓冲液(10mmol/L醋酸铵溶液1000ml加三乙氨1.5ml,调pH值4.0±0.1)(55:45),流速1ml/min,检测波长为244nm。结果:在50～500μg/ml范围内,线性关系良好(r=0.9999),回收率为100.04%,RSD为0.26%。结论:本方法简便,准确,专属,可用于该片的质量控制。Objective： To establish a method of content detem,.ination of ambroxol hydrochloride orally disintegrating tablets by liPid.Methods： The SHIMADAZUC18 column（ 15mm×4.6mm, 5μm）was used.The mobile phase consisted of methanol-acetate buffer（ 10mmol · L^-1 arrnnonium acetate solution add triethylamine 1.5ml, adjusted pH to 4.0± 0.1） （55： 45）, at a flow rate of 1 ml · min^-1, the detective wavelength was 244nm.Results： There was a good liner relationship within the range of 50- 500μg · ml^-1（r =0.9999） .The recovery of the method was 100.19%, the RSD was 0.52%. Conclusion： the method is specific of ambroxol hydrochloride orally disintegrating Tablets.

关 键 词：盐酸氨溴索 口腔崩解片 高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学]