Advanced Analytical And In Vitro Assessment of Topatecan Encapsulated in Gum Ghatti Nanoparticles

Abstract

Using the everted gut sac technique and a variety of modulators, the current research aims to develop a straightforward, sensitive, robust, and dependable method for estimating GGNPs in physiological media to evaluate their permeability profile. A column with a mobile phase of acetonitrile and 0.045 M sodium dihydrogen phosphate dihydrate buffer containing the ion-pair agent heptane sulphonic acid sodium salt (0.0054 M), pH 3, was used to achieve separation. A detector was used for analysis, and the flow rate was maintained at 1 ml/min. The calibration data demonstrated a strong linear relationship (r2 = 0.9999) between the peak area and the drug concentration. The linearity was found to be between 0.060 and 10.0 g/ml. Approximately 0.020 g/ml and 0.060 g/ml served as the detection and quantification limits, respectively. The developed method was found to be accurate (recovered content of topatecan in the presence of various modulators ranged from 96.11-101.51%, within the acceptable range of 80-120%), specific, and robust (% RSD 2), as well as precise (RSD 1.5% for repeatability and 2.55% for intermediate precision). With UV detection at 220 nm, the mobile phase was delivered at a flow rate of 0.3 ml/min. Topatecan, its seven impurities, and degradation products were successfully separated after the 8-minute run time. In terms of specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness, the developed method was validated in accordance with ICH guidelines. The ability to characterize surface chemistry in conventional IR spectroscopy of nanomaterials is limited. We recorded IR spectra of various solvents within a fixed bed of the nanopowder to be tested to circumvent these limitations. By affecting the hydrogen-bonding network in the solvent through molecular interactions, the use of water and various alcohols as solvents makes it possible to characterize the surface chemistry of the nanomaterial. Topatecan hydrochloride assay determination in pharmaceutical dosage forms was also feasible with this approach.