Brain Gut Sugar (BGS) is a sugar solution consisting of Sucrose, Lactulose, Mannitol, and Sucralose. It has been used in clinical research to study brain-gut interactions in patients with digestive and alcohol use disorder. Previously, the product was tested following USP monographs for each active ingredient one by one—a very time-consuming and non-preferable approach. An HPLC procedure was developed in-house for quantitatively testing active ingredients within same sample run—the feasibility study is presented here for the application of following product stability. The procedure is an isocratic assay using water as mobile phase, flow rate 0.45 mL/min, an Agilent Hi-Plex Ca 300x7.7 mm column at 80oC is used for separation, and a Refractive Index Detector at 50oC is used for detection. To determine if the procedure was stability indicating, the most critical factor of feasibility, namely forced degradation study of Sucrose, Lactulose, Mannitol and Sucralose, was performed. This testing included subjecting the sugars to basic, acidic, oxidizing, and heat conditions. Solutions of each sugar under stressed conditions were tested to find out where the degradation products eluted and if new peaks overlapped with any active ingredient peaks, thus effecting the analysis of BGS solution. Listed in the Table are the remain percentage of Sucrose, Lactulose, Mannitol, and Sucralose stressed with 1N NaOH, 1N HCl, 3% H2O2, and 60oC over 24 hours. List of peaks and retention times are not presented here due to space limitation. Degradants peaks of some components observed interfere with analysis of the others. Less stringent stress conditions were also studied. Details of these studies will be presented in final presentation. Results showed that if pH is above 4.1, the solution is stable. It was demonstrated that BGS solution is not chemically stable under the stressed conditions studied. Furthermore, when stressed, degradants from some of the four sugars interfere with analysis of the others. However, the conditions tested are to be considered ‘worst-case’ scenarios and not all of the stressed conditions used are applicable under actual conditions of use. Under recommended storage conditions and within a specific pH range, it was deemed feasible to use the procedure for testing the BGS product and its stability over time.

Feasibility study of HPLC-RID assay procedure for the analysis of brain gut sugar solution

ACS Fall 2020 Virtual Meeting

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