盐酸乙胺丁醇分散片溶出度检查方法的建立  

Establishment of the dissolution test of ethambutol hydrochloride dispersible tablets

作　　者：冯金元[1] 丁怡[1] 李志芳[1] 石颖 张玉英[1] 章娟[1] FENG Jin-yuan;DING Yi;LI Zhi-fang(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国处方药》2023年第8期50-53,共4页Journal of China Prescription Drug

基　　金：广州市市场监督管理局科技项目(2021kj46);广东省药品监督管理局科技创新项目(2020ZDB06)。

摘　　要：目的 建立盐酸乙胺丁醇分散片的溶出度检查方法,为该制剂的质量控制提供参考。方法 通过对溶出度试验条件的考察,最终确定采用桨法,以900 ml磷酸盐缓冲液(pH6.8)作为溶出介质,转速为50 r/min,溶出时间为30 min,限度为标示量的80%。采用HPLC法测定盐酸乙胺丁醇的溶出量,色谱柱为Agilent Zorbax SB-C_(18)柱(4.6 mm×250 mm,5μm);流动相为醋酸铵/醋酸铜溶液(取醋酸铵50 g和醋酸铜0.2 g,加水溶解并稀释至1 000 ml,用冰醋酸调节至pH值5.0)-甲醇(80∶20,V/V);检测波长为270 nm。结果 盐酸乙胺丁醇在26.151~500.993μg/ml的浓度范围内线性关系良好(r=0.999 97),平均回收率为100.58%,RSD=1.05%(n=9)。来自厂家的2批样品在30 min取样检测时溶出度均在80%以上。结论 建立的方法专属性强,有一定的区分力,可用于盐酸乙胺丁醇分散片的溶出度检查。Objective To establish a method for the dissolution test of ethambutol hydrochloride dispersible tablets and provide a reference for the quality control of this preparation.Methods Through the investigation of the dissolution test conditions,the paddle method was finally determined to be adopted.900 ml of phosphate buffer solution(pH6.8) was used as the dissolution medium.Rotated the paddle at 50 revolutions per minute,and withdrew sample solution at 30 minutes.The amount in dissolution solution for each tablet shouldn't be less than 80% of the labeled amount.The dissolution rate of ethambutol hydrochloride was determined by HPLC on an Agilent Zorbax SB-C_(18) column(4.6 mm ×250 mm,5μm).The mobile phase consisted of ammonium acetate/copper acetate solution(50 g ammonium acetate and 0.2 g copper acetate was dissolved and diluted to 1 000 ml with water,and adjusted pH to 5.0 with glacial acetic acid)-methanol(80∶20,V/V).The detection wavelength was set at 270 nm.Results The linear range of ethambutol hydrochloride was 26.151 ~ 500.993 μg/ml(r = 0.999 97).The average recovery was 100.58% and RSD was 1.05%(n = 9).The dissolution rates of the two batches of samples from the manufacturer were above 80% at 30 minutes.Conclusion The established method is specific and discriminative,and can be used for the dissolution test of ethambutol hydrochloride dispersible tablets.

关 键 词：盐酸乙胺丁醇 分散片 溶出度 HPLC 

分 类 号：R927.2[医药卫生—药学]