Ion chromatography method and validation for the determination of sulfate and sulfamate ions in topiramate drug substance and finished product

Journal of Chromatography. B, Biomedical Sciences and Applications
A P MicheelH Y Guh

Abstract

A stability-indicating assay method has been developed for monitoring topiramate degradation in drug substance and finished product by quantifying sulfamate and sulfate ions. Topiramate in the solid state is stable under ambient conditions but can degrade under stress conditions (elevated temperatures and humidities). This method detects and quantitates sulfamate and sulfate ions (the inorganic part of the decomposition) and in conjunction with an assay method for topiramate and its known organic degradation product provides total molar accountability. The chromatographic system consists of a sodium hydroxide gradient (2-25 mM) and an anion-exchange HPLC column and an anion suppressor. The analysis is complete in 30 min. The method utilizes the same sample preparation as the topiramate assay method which increases sample efficiency and throughput. The method has been validated for analysis of degraded and nondegraded topiramate drug substance and finished product.

Citations

Aug 16, 2015·Journal of Chromatographic Science·Eduardo Costa PintoValéria Pereira de Sousa
Apr 16, 2015·Biomedical Chromatography : BMC·Eduardo Costa PintoValéria Pereira de Sousa
Jul 14, 2012·Journal of Analytical Methods in Chemistry·Nahla N SalamaMohammed I Walash
Oct 9, 2018·Toxicological Sciences : an Official Journal of the Society of Toxicology·Elisabet TeixidóStefan Scholz
Dec 18, 2013·Chemical Reviews·William Spillane, Jean-Baptiste Malaubier
Jun 29, 1999·Analytical Chemistry·R K Gilpin, L A Pachla

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.