Qualitative Portrayal of Esomeprazole Magnesium by Exploring Diverse Analytical and Investigative Approaches

Abstract

Purpose: The present study was intended to qualitatively analyze and drive meaningful statistics for Esomeprazole magnesium; to establish its inherent properties qualitatively & quantitatively. Methods: Esomeprazole magnesium was analyzed using various traditional & modern analytical and investigative tools viz FTIR, HPLC, UV spectroscopy, X-ray diffraction, zetasizer. Results: The absorption maxima were found at 301 nm with UV Spectrophotometric and HPLC analysis. The particle size of the drug was analyzed through Malvern zetasizer employing water as diluent and found to be 11.818 µm. The quantitative solubility of Esomeprazole magnesium was predicted in various solvents at 25 0C and found that it was most soluble in methanol and was least soluble in distilled water. Solubility was also found to be pH-dependent. Solubility increases with an increase in pH. The order of solubility determined was; Methanol (1.214 mg/ml) > Phosphate buffer pH- 7.4 (0.521 mg/ml) > Simulated Intestinal fluid pH-6.8 (0.475 mg/ml) > Phosphate buffer pH- 6.8 (0.466 mg/ml) > Simulated Gastric fluid pH-1.2 (0.147 mg/ml) > 0.1 N HCl (0.131 mg/ml) > Distilled water (0.017 mg/ml). The predicted log P value was found to be 2.39. Conclusion: Esomeprazole magnesium was qualitatively analyzed using various analytical techniques to establish its inherent properties quantitatively. It is an off-white amorphous powder with a characteristic obnoxious odor and slightly bitter taste. The drug was identified through FTIR, using the classification of characteristic peaks of functional groups in the spectrum and also additionally through analytical methods viz HPLC, UV spectroscopy and found the absorption maxima at 301 nm. The linear regression analyses of a standard plot from UV spectrophotometric analysis demonstrate an unswerving relationship in the concentration range of 5-30μg/ml. The log P value indicates that the drug is significantly lipophilic. Various Micromeritic parameters like the Angle of repose, compressibility index, and Hausner's ratio predict the inherent flow properties of Esomeprazole magnesium as Fair (aid not needed). The present study will be an asset in the development of a modified released quick action formulation (Tablet-in-Tablet), to offer quick and protracted relief in gastritis and allied disorders.