Validation of quantitative ¹H NMR method for the analysis of pharmaceutical formulations

Química Nova

Embrapa Instrumentação, São Carlos, Brasil¹  Universidade de São Paulo, São Carlos, Brasil¹  Colnago, Luiz Alberto¹  Santos, Maiara da S.¹ 

关键词: qNMR;    pharmaceutical;    validation.;   

DOI  :  10.1590/S0100-40422013000200020

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

The need for effective and reliable quality control in products from pharmaceutical industries renders the analyses of their active ingredients and constituents of great importance. This study presents the theoretical basis of 1H NMR for quantitative analyses and an example of the method validation according to Resolution RE Nº 899 by the Brazilian National Health Surveillance Agency (ANVISA), in which the compound paracetamol was the active ingredient. All evaluated parameters (selectivity, linearity, accuracy, repeatability and robustness) showed satisfactory results. It was concluded that a single NMR measurement provides structural and quantitative information of active components and excipients in the sample.

【 授权许可】

Unknown