Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF DIGOXIN CONTROLLED RELEASED FROM POLYMERIC IMPLANTS

Abstract

A spectrophotometric method was developed and validated for the determination of digoxin incorporated into poly(ε-caprolactone) implants and released from them. The detection of the drug was carried out in 220 nm. The method was linear (R2 > 0.99) over the range of 4 to 24 μg mL-1, precise (RSD < 5%), accurate (mean recoveries from 110.5% and 101.3%), and had a theoretical quantitation limit equal to 0.008 μg mL-1. The method showed robustness, remaining unaffected by deliberated variations in spectrophotometric conditions. The validated analytical method was successfully applied for the unequivocal quantitation of the digoxin incorporated into the polymeric implants, demonstrating the uniform distribution of the drug into the systems. Finally, the validated spectrophotometric method provided the determination of the digoxin leached from the poly(ε- caprolactone) implants, indicating the controlled in vitro and in vivo release of the digoxin incorporated into the polymeric matrix.

Keywords: validation; spectrophotometric method; digoxin; polymeric implants; in vitro and in vivo controlled release.