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Stability-Indicating High-Performance Liquid Chromatography Assay for the Determination of Sulthiame in Pharmaceutical Dosage Forms

A stability-indicating assay by reversed-phase high performance liquid chromatography method was developed and validated for the determination of sulthiame (STM). The chromatographic separation was achieved on a reversed-phase NovaPack C18 column and an isocratic mobile phase consisting of deionized water:methanol (70:30, v/v). The flow rate was 1.0 mL/min (ultraviolet detection at 210 nm). The STM was separated within 2.83 min. The linearity of the method was demonstrated in the range of 20.0–200.0 µg/mL and a coefficient of determination of r² = 0.9999. The limits of detection and quantification were 4.2 and 9.5 µg/mL, respectively. The intraday and interday precisions were less than 1%. Accuracy of the method ranged from 98.3% to 101.7%, with a relative standard deviation of <1%. STM was degraded by accelerated breakdown in alkaline, acidic, or oxidative stress conditions. This method allows accurate and reliable determination of STM for drug stability assay in pharmaceutical studies.

Autoren:   Ammar Haidar, Sofiane Kabiche, Elyes Majoul, Issa-Bella Balde, Jean-Eudes Fontan, Salvatore Cisternino and Joël Schlatter
Journal:   Analytical Chemistry Insights
Band:   2016
Ausgabe:   1
Jahrgang:   2016
Seiten:   59
DOI:   10.4137/ACI.S38656
Erscheinungsdatum:   16.09.2016
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