Análise químico-farmacêutica e avaliação da estabilidade de pimobendana em formas farmacêuticas diversas

Abstract

Pimobendan (PMB) is used as a first-line treatment for heart failure, in combination with other drugs; however, it presents physicochemical characteristics that make its manipulation challenging. The developed and validated method followed the guidelines of RDC No. 166/2017 (ANVISA), the ICH Q2(R1) guideline, and Appendix F of AOAC International. The method demonstrated linearity over the range of 2.0–14.0 µg/mL (r > 0.999), with limits of detection and quantification determined at 0.12 µg/mL and 0.25 µg/mL, respectively. Precision showed a relative standard deviation (RSD) below 1.9%, and accuracy presented recoveries between 98.0–102.0%. A simple, rapid, and cost-effective UV/Vis spectrophotometric method was developed and validated for the quantification of PMB in solid (capsules) and liquid (anhydrous oral solutions) pharmaceutical formulations. The analysis was performed using zero-order spectra, employing 0.1 mol/L HCl solution as the solvent and a maximum absorption wavelength at 329 nm. The method proved to be selective, robust against the evaluated deliberate variations, and fully applicable to the analysis of commercial samples, yielding consistent results in agreement with the labeled content. Therefore, the developed procedure meets regulatory requirements and is suitable for routine analyses in quality control laboratories.