Micelle enhanced and native spectrofluorimetric methods for determination of sertindole using sodium dodecyl sulfate as sensitizing agent

• Two validated stability indicating spectrofluorimetric (native and micelle enhanced) methods had been developed to determine antipsychotic drug Sertindole.
• Due study of different factors affecting fluorescence native and micelle enhanced had been presented.
• The aim was to achieve high sensitivity and to be environment and cost saving by using less toxic expensive solvents and reagents.
• This was achieved by creating an aqueous microenvironment for Sertindole molecules using micelles created by the anionic surfactant Sodium dodecyl sulfate to sequester the drug in the hydrophobic micelle core protected from the quenching effect of the aqueous solvent.
• The methods were validated in accordance to ICH guidelines, applied for assay determination of Sertindole in bulk powder and pharmaceutical preparation and were statistically compared to the manufacturer methods.

Two stability indicating spectrofluorimetric methods were developed and validated for the determination of sertindole (SER) in the presence of its acid and oxidative degradates at λex 257 nm and λem 335 nm. Method A was based on measuring the native fluorescence of SER using isopropanol as solvent. Method B was based on the enhancement of native fluorescence of SER quenched in aqueous media by using micellar microenvironment created by sodium dodecyl sulfate (SDS) anionic micelles using Britton Robinson Buffer (BRB) pH 3.29 as solvent. Different factors affecting fluorescence intensity; both native and enhanced, were carefully studied to reach the optimum conditions of measurements. The proposed spectrofluorimetric methods were validated in accordance with ICH guidelines and were successfully applied for the determination of SER in bulk powder and pharmaceutical preparation with high sensitivity and stability indicating power. They were also statistically compared to the manufacturer methods with no significant difference in performance.

The proposed native and micelle enhanced spectrofluorimetric methods are rapid, simple, precise and specific; so it could be applied for routine analysis in quality control laboratories for quantitative determination of sertindole in drug substance, drug products as well as in the presence of its degredates using environment friendly and inexpensive materials.Figure optionsDownload as PowerPoint slide