Analytical Instrumental and In Vitro Evaluation of Irinotecan Gum Ghatti Nano Particles

Abstract

The present work aims to develop a simple, sensitive, robust, and reliable method for estimating irinotecan GGNPs in physiological media to assess its permeability profile using the everted gut sac technique in the presence of various modulators. Separation was achieved using a column with a mobile phase consisting of acetonitrile and 0.045 μM sodium dihydrogen phosphate dihydrate buffer containing ion-pair agent heptane sulphonic acid sodium salt (0.0054 μM), pH 3. The flow rate was maintained at 1 ml/min, and analysis was performed at 254.9 nm using a detector. Calibration data showed an excellent linear relationship between peak area and drug concentration (r² = 0.9999). The mobile phase was delivered at a flow rate of 0.3 ml/min with ultraviolet detection at 220 nm. The run time was 8 minutes, within which irinotecan and its seven impurities and degradation products were satisfactorily separated. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness. In conventional IR spectroscopy of nanomaterials, the capability of characterizing surface chemistry is limited. To overcome these limitations, we recorded IR spectra of different solvents inside a fixed bed of the nanopowder to be tested. Using water and different alcohols as solvents enables the characterization of the nanomaterial’s surface chemistry via the molecular interactions affecting the hydrogen-bonding network in the solvent. This method was also suitable for the assay determination of irinotecan hydrochloride in pharmaceutical dosage forms.