Development of Bio‐analytical Methodology and Physico‐chemical Characterization of Novel Compound RED

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ObjectiveThis study was carried out to develop the analytical methodology and limited characterization of the novel compound codenamed RED. The structure of the novel molecule is being withheld to protect the intellectual rights and patent issues involved.IntroductionThe molecule under investigation is a novel molecule that is custom manufactured for research purpose only. It is believed to have anti‐cancer activity and thus is a subject of interest and investigation.MethodThe UV‐Visble absorption spectra of the compound is established. A reverse phase liquid chromatographic method is developed to separate RED from its close structural analogs code named RmBr, RpM and RPh using a Xorbax Eclipse XDB‐C18 as stationary phase. The mobile phase is a combination of acetonitrile and water used in a continuously changing concentration gradient. Standard curve was prepared between concentrations of 0.5–10 mcg/ml with RmBr as internal standard; limit of detection (LOD) and quantitation (LOQ) was established. Statistical analysis of the data was carried out. The solubility of the compound in water, water containing 5% DMSO and water containing 5% DMSO and 5% Cremaphor was established by vortexing and ultra‐centrifugation. The stability profile of the compound in water and water containing 5% DMSO and 5% Cremaphor is established in glass and polypropylene container.ResultsWithin the specified range the standard curve yielded a slope of 0.1631 (±0.0045) and an intercept of 0.0035 (±0.0054) and good linearity (R2≥0.999). RED solubilities are found to be 0.34, 0.7 and above 5 mcg/ml in water, 5% DMSO and 5% DMSO+5% Cremaphor ( a commonly used bio‐compatible solubilizing agent) respectively. The compound is found to be stable (≥90% of original content) for more than 7, 9 and 7 days in water, 5% DMSO and 5% DMSO+5% Cremaphor respectively when preserved in room temperature in glass containers. However, the compound Red rapidly degenerates when kept in room temperature in polypropylene bottles. The shelf life (>90% of original) of Red in polypropylene containers in room temperature is less than a day. The stability studies were carried out in both transparent and amber colored glass bottles, the compound was found to stable up to 7 days. The stability is not dependent on light within the time period of investigation.ConclusionThe project is successful in establishing an analytical methodology for RED that is repeatable, robust, accurate and precise in the range. The solubility and stability of the compound in common aqueous solvents have been established. More work is required achieve a complete physico‐chemical characterization of compound.Support or Funding Information*This work has been financially supported by University of Findlay, College of Pharmacy fundsThis abstract is from the Experimental Biology 2018 Meeting. There is no full text article associated with this abstract published in The FASEB Journal.