Title : Separation and assay of sorbitol and sucralose binary mixture by extraction using HPLC/ELSD method
Abstract:
An accurate, rapid and sensitive novel chromatographic method has been developed, validated and applied for the determination of Sucralose and Sorbitol; each compound in the presence of the other, in their binary mixtures. Isosweet ® artificial sweetener is a co-formulation of a non-caloric sweetener Sucralose and an excipient Sorbitol. Quality control assay of the cited formulation is an analytical challenge. Both sugars are non-chromophoric compounds, as well as they share similar chemical and physical properties. The present study aims at a selective separation of both compounds by extraction step with ethyl acetate prior to column injection. HPLC / Evaporative Light Scattering Detection has been used with the C18 column stationary phase and a mixture of acetonitrile and water as the mobile phase. All operating conditions were optimized for maximum sensitivity. Full validation was carried out with respect to ICH guidelines. Linear ranges for Sucralose and Sorbitol reached 100-700 ppm and 200-990 ppm respectively. Non-linear responses of ELSD were converted into Log-values and correlated with their corresponding concentrations, resulting in coefficients around 0.99 values. Satisfactory recovery results have been obtained upon application of the suggested method for synthetic mixtures and marketed pharmaceutical formulations.
Audience Take Away Notes:
- Novel Chromatographic method for separation and assay of ISoSweet® sachets.
- The routine quality control analytical method is developed and validated.
- Analytical and industrial purposes are fulfilled. (Research and QC lab)
- The great challenge is the accurate analysis of non-chromophoric compounds.
- Yes, the suggested method in the study is first to be designed and applied.
- Accuracy, time-saving, relatively eco-friendly and affordability.
