Validation of a Chromatographic Method for the Quantification of Furvina in 0.15% Dermofural Ointment

Abstract

Introduction: Furvina, developed by the Center for Bioactive Chemicals at Marta Abreu Central University, is the active pharmaceutical ingredient in 0.15% Dermofural, used to treat dermatological infections. Its reintroduction to the market requires ensuring quality and stability through a validated analytical method.

Objective: To validate a high-performance liquid chromatography method for quantifying furvina in 0.15% Dermofural.

Methods: The analytical procedure was based on liquid-liquid extraction of furvina with acetonitrile, followed by reverse-phase high-performance liquid chromatography, using a mobile phase of acetonitrile:water (80:20, v/v) at a flow rate of 0.7 mL/min and detection at 375 nm. Certified material (>98% purity) was used. Validation followed Regulation 40-2014 of the State Center for the Control of Medicines, Equipment, and Medical Devices; the International Council for Harmonization (ICH) Q2(R2) guideline; and statistical analysis using Statgraphics Centurion 19.

Results: The method demonstrated accuracy with a mean recovery of 99.25% (coefficient of variation = 1.20%), and a calculated t-test value (1.8757) lower than the tabulated value (2.1199). Precision was assessed for repeatability (mean = 99.39%, coefficient of variation = 0.28%) and intermediate precision using multifactorial ANOVA, with p-values > 0.05 and a 95% confidence level. Linearity showed a correlation coefficient (r = 0.9999), with confidence intervals for the slope (1.0002–1.0025) and intercept (-0.0217–0.0165) and theoretical values (1 and 0). Specificity confirmed the absence of interferences in quantification.

Conclusions: The validated method complies with regulatory standards for accuracy, precision, linearity, and specificity. Its consistency ensures applicability in quality control and stability studies.