Desenvolvimento e validação de um método analítico por CLAE para quantificação de ácido ursólico em dispersões sólidas

Abstract

Ursolic acid is a natural molecule that presents several pharmacological properties. In this work, an analytical method by RP-HPLC has been developed and validated for quantification of this drug in the solid dispersions, using PEG 6000 and Poloxamer 407 as polymers. The method was specific, linear in the range of 1.0-50.0 µg mL-1 (r<0.99), precise (CV < 5% for both inter- and intra-assays), accurate (maximum deviation of ± 13%), and robust to the parameters evaluated. This method has proved to be simple and useful for ursolic acid determination in solid dispersions, enabling its determination in pharmaceutical dosage form.

Keywords

• ursolic acid
• quantitative analyses
• HPLC