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 r (2) = 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.
Service de Pharmacie, Hôpital Jean Verdier, APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Bondy, France.
Ammar
A
Haidar
Service de Pharmacie, Hôpital Jean Verdier, APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Bondy, France.
Sofiane
S
Kabiche
Service de Pharmacie, Hôpital Jean Verdier, APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Bondy, France.
Elyes
E
Majoul
Service de Pharmacie, Hôpital Jean Verdier, APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Bondy, France.
Issa-Bella
IB
Balde
Service de Pharmacie, Hôpital Jean Verdier, APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Bondy, France.
Jean-Eudes
JE
Fontan
Service de Pharmacie, Hôpital Jean Verdier, APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Bondy, France.
Salvatore
S
Cisternino
Service de Pharmacie, Hôpital Jean Verdier, APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Bondy, France.
Joël
J
Schlatter
forced degradation; liquid chromatography; stability indicating; sulthiame