HPLC测定替米沙坦片含量方法学验证  

Assay Validation of Telmisartan Tablets by HPLC

作　　者：陈晓春 蒋玲 彭奎毓 张立仁 张朝侠 Chen Xiao-chun;Jiang Ling;Peng Kui-yu;Zhang Li-ren;Zhang Zhao-xia(Jiangsu Wanbang Biopharmaceuticals,Jiangsu Xuzhou 221004)

机构地区：[1]江苏万邦生化医药股份有限公司,江苏徐州221004

出　　处：《生物化工》2020年第2期45-48,共4页Biological Chemical Engineering

摘　　要：目的:建立一种高效液相色谱法用于测定替米沙坦片含量,并进行方法学验证。方法:参照日本药典JP16第二种增补本中替米沙坦片的含量测定法,采用高效液相色谱法测定替米沙坦片含量。结果:专属性、滤膜吸附、线性、重复性、中间精密度、准确度、溶液稳定性和耐用性试验的结果均符合要求。结论:HPLC法快速、准确、专属性高,可用于替米沙坦片的含量测定。Objective:To established and validated a method of determining assay of Telmisartan Tablets by HPLC.Methods:The content of Telmisartan Tablets was determined by HPLC according to the second supplement of JP16.Results The tests of specificity,membrane adsorption,linearity,repeatability,intermediate precision,accuracy,solution stability and robustness are carried out,and the results meet the requirements.Conclusions:HPLC method is fast,accurate and specific,and can be used for the determination of assay of Telmisartan Tablets.

关 键 词：替米沙坦 含量 方法学验证 高效液相色谱 

分 类 号：R927.2[医药卫生—药学]