Characterization of Five Oxidative Degradation Impurities and One Process Impurity of Suvorexant Drug Substance by LC-MS/MS, HR-MS and 1D, 2D NMR: Validation of Suvorexant Drug Substance and Process Impurities by HPLC and UPLC.

Journal of Chromatographic Science
Nagaraju RajanaK Balakumaran

Abstract

During the oxidative (10% H2O2) degradation of suvorexant drug substance, around 1.0% of one impurity and less than 1.0% four impurities were found by a new high-performance liquid chromatography (HPLC) assay and related substance method. The mass numbers of 1.0% impurity was 469 [M + H]+, remaining four impurities were 172 [M + H]+, 467 [M + H]+, 483 [M + H]+ and 485 [M + H]+. The 469 [M + H]+, 485[M + H] and 172 [M + H]+ impurities were characterized by using the LC-MS/MS, HR-MS and 1D, 2D NMR spectroscopic data. The 172 [M + H]+ impurity was prepared synthetically and co-injected in HPLC. The retention time of synthesized 172 [M + H]+ impurity was matching with the unknown degradation impurity in HPLC. The developed mass compatible HPLC and ultra performance liquid chromatography methods were validated for drug substance and process impurities by following ICH Q2 (R1) guidelines.

References

Jun 14, 2002·Journal of Pharmaceutical and Biomedical Analysis·K V S R Krishna ReddyK Vyas
Oct 9, 2002·Journal of Pharmaceutical and Biomedical Analysis·K V S R Krishna ReddyK Vyas
Mar 1, 2003·Journal of Pharmaceutical and Biomedical Analysis·J Moses BabuK Vyas
May 24, 2003·Journal of Pharmaceutical and Biomedical Analysis·Y Ravindra KumarK Vyas
Jul 11, 2003·Journal of Pharmaceutical and Biomedical Analysis·K V S R Krishna ReddyK Vyas
Oct 21, 2003·Journal of Pharmaceutical and Biomedical Analysis·K V S R Krishna ReddyK Vyas
Jun 15, 2004·Journal of Pharmaceutical and Biomedical Analysis·U SatyanarayanaJ Tirupathi Reddy
Sep 1, 2004·Journal of Pharmaceutical and Biomedical Analysis·K V S R Krishna ReddyK Vyas
Dec 1, 2005·Journal of Pharmaceutical and Biomedical Analysis·P SattanathanP Sudhakar
Dec 6, 2005·Journal of Pharmaceutical and Biomedical Analysis·P SudhakarK Mukkanti
Dec 7, 2005·Journal of Pharmaceutical and Biomedical Analysis·R Vasu DevN Srinivasa Rao
Dec 1, 2006·Journal of Pharmaceutical and Biomedical Analysis·Ganta Madhusudhan ReddyK Mukkanti
Jul 17, 2007·Journal of Pharmaceutical and Biomedical Analysis·Ganta Madhusudhan ReddyK Mukkanti
Aug 30, 2008·Journal of Pharmaceutical and Biomedical Analysis·M SaravananBollikonda Satyanarayana
May 15, 2015·Journal of Pharmacology & Pharmacotherapeutics·Ashok K DubeyPramod K Mediratta
Sep 8, 2015·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·S A BreidingerE J Woolf
Oct 20, 2015·Therapeutic Advances in Drug Safety·Danielle N Rhyne, Sarah L Anderson
Feb 13, 2016·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Donghui CuiThomayant Prueksaritanont
Nov 9, 2016·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Mariah Carson, Sarah Kerrigan
Oct 11, 2017·Australasian Psychiatry : Bulletin of Royal Australian and New Zealand College of Psychiatrists·Nicholas A KeksSimone Keogh

❮ 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.