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Updated: Jun 4, 2026
Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
Stability-indicating spectrofluorimetric method for the assay of ziprasidone in capsules
Mohamed I Walash1, Fathalla Belal, Nahed El-Enany
1Department of Analytical Chemistry, Faculty of Pharmacy, University of Mansoura, 35516, Mansoura, Egypt.
Abstract:
A simple, rapid and highly sensitive spectrofluorimetric method was developed for determination of ziprasidone hydrochloride (ZPS) in capsules. The method is based on measuring the native fluorescence of ZPS in acetate buffer of pH 4.5 at 398 nm after excitation at 315 nm. The fluorescence-concentration plot was rectilinear over the range of 0.05-0.80 μg mL(-1) with a lower detection limit (LOD) of 6.0 ng mL(-1) and quantification limit (LOQ) of 20.0 ng mL(-1). The method was fully validated and successfully applied to the determination of ZPS in its capsules with average percentage recovery of 99.7 ± 1.4. The method was extended to stability study of ZPS. The drug was exposed to acidic, alkaline, oxidative and photolytic degradation according to ICH guidelines. Moreover, the method was utilized to investigate the kinetics of the alkaline, acidic and oxidative degradation of the drug. A proposal for the degradation pathways was postulated.
