Development and validation of a dissolution test for telithromycin in coated tablets

Química Nova

Schapoval, Elfrides E. S.¹  Universidade Federal de Santa Maria, Santa Maria, Brasil¹  Paim, Clésio S.¹  Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil¹  Vaucher, Lauren C.¹  Lange, Alini D.¹ 

关键词: telithromycin;    dissolution test;    validation.;   

DOI  :  10.1590/S0100-40422009000500041

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

A dissolution test for telithromycin tablets was validated and developed. In order to choose the most discriminatory one, the conditions to carry out are 900 mL of sodium phosphate buffer at pH 7.5, paddles at 50 rpm stirring speed, time test set to 60 min and using USP apparatus 2 with paddles. The UV spectrophotometric method for determination of telithromycin released was developed and validated. The method presents linearity (r = 1) in the concentration range of 20-60 µg/mL. Precision and recoveries were good, 100.62 and 97.06%, respectively. The method was successfully used for the dissolution test of telithromycin tablets.

【 授权许可】

Unknown