title: Micelle enhanced and native spectrofluorimetric methods for determination of sertindole using sodium dodecyl sulfate as sensitizing agent.
abstract: 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 λ(ex) 257 nm and λ(em) 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) pH3.29 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.
authors.affiliation: Analytical Pharmaceutical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
authors.forename: Amira M
authors.initials: AM
authors.lastname: El-Kosasy
authors.affiliation: Analytical Pharmaceutical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
authors.forename: Lobna A
authors.initials: LA
authors.lastname: Hussein
authors.affiliation: Analytical Pharmaceutical Chemistry Department, National Organization for Drug Control and Research (NODCAR), Egypt. Electronic address: nehalsedki82@gmail.com.
authors.forename: Nehal G
authors.initials: NG
authors.lastname: Sedki
authors.affiliation: Analytical Pharmaceutical Chemistry Department, National Organization for Drug Control and Research (NODCAR), Egypt.
authors.forename: Nahla N
authors.initials: NN
authors.lastname: Salama
mesh_terms: D019840:2-Propanol / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D057927:Hydrophobic and Hydrophilic Interactions; D007093:Imidazoles / Q000032:analysis*; D007211:Indoles / Q000032:analysis*; D008823:Micelles; D012015:Reference Standards; D015203:Reproducibility of Results; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry*; D012997:Solvents; D013050:Spectrometry, Fluorescence / Q000379:methods*; D013501:Surface-Active Agents / Q000737:chemistry
chemical_list: D007093:Imidazoles; D007211:Indoles; D008823:Micelles; D012997:Solvents; D013501:Surface-Active Agents; D012967:Sodium Dodecyl Sulfate; C066304:sertindole; D019840:2-Propanol
keywords: Micelles; Sertindole; Spectrofluorimetry; Stability; Validation