Development and validation of an UV spectrophotometric method for the determination of aliskiren in tablets

Quimica nova

Diefenbach, Isabel Fração¹  Rolim, Clarice Madalena Bueno¹  Secretti, Leonardo Trevisan¹  Wrasse-Sangoi, Micheli¹  Sangoi, Maximiliano da Silva² 

[1]Universidade Federal de Santa Maria, Santa Maria, Brasil

[2]Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil

关键词: aliskiren;    pharmaceutical formulation;    UV spectrophotometry.;   

DOI  :  10.1590/S0100-40422010000600021

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

For determinationof aliskiren in commercial samples, an analytical UV spectrophotometric methodwas developed and validate according to ICH guideline. The method was linearin the range between 40 and 100 μgmL-1 (r2 = 0.9997, n = 7) and exhibitedsuitable specificity, accuracy, precision, and robustness. It is simple, ithas low cost, and it has low use polluting reagents. Therefore, the proposedmethod was successfully applied for the assay and dissolution studies of aliskirenin tablet dosage forms, and the results were compared to a validated RP-LC method,showing non-significant difference (P > 0.05).

【 授权许可】

CC BY