Development and validation of gel-chromatographic and spectrophotometric methods for quantitative analysis of bioactive copper complexes in new antihypocupremical formulations

Gel-permeation chromatographic (GPC) and visible spectrophotometric methods have been developed and validated for quantitative analysis of complexes of copper(II) with the polysaccharides pullulan and dextran, active pharmaceutical compounds in new antihypocupremical formulations. Linearity, precision, accuracy, specificity, and limits of detection (LOD) and quantification (LOQ) were determined in accordance with ICH Q2(R1) guidelines. GPC was performed isocratically with redistilled water as mobile phase at a flow rate of 1 mL min -1 Visible spectrophotometry was performed in water, using 640 nm for direct assay of the copper(II) complex with pullulan and dextran. The calculated F and t values at the 95% confidence level were less than the theoretical values, showing there were no significant differences between the performance of the methods.