Enantiomeric impurity analysis using circular dichroism spectroscopy with United States Pharmacopeia liquid chromatographic methods

Journal of Pharmaceutical and Biomedical Analysis
Douglas KirkpatrickMichael Trehy

Abstract

Over 300 chiral drug substances lack official United States Pharmacopeia (USP) methods for the enantiomeric purity determination. Because enantiomeric analysis typically requires specialized methods for each drug compound, developing protocols for each of these 300+ substances would be an expensive and laborious endeavor. Alternatively, if a detector capable of determining the enantiomeric composition without chiral separation could be used with certain drug compounds, this could be implemented relatively rapidly into official testing monographs. Circular dichroism (CD) detection following HPLC (HPLC-CD) has been proposed for this purpose but studies performed thus far have not prioritized its compatibility with validated regulatory methods. In this study, HPLC-CD was evaluated for enantiomeric purity determinations of 13 drug substances using HPLC methods consistent with assay protocols described in United States Pharmacopeia (USP) monographs. Of these selected substances, three (sitagliptin, timolol, and levalbuterol) showed no CD activity and one other (levofloxacin) could not be analyzed due to incompatibility of the mobile phase with the CD detector. For the remaining 9 substances, method validation was performed to determ...Continue Reading

References

Apr 1, 2000·Lancet·G T Tucker
Feb 24, 2001·Journal of Chromatography. a·N M MaierW Lindner
Oct 16, 2001·Journal of Pharmaceutical and Biomedical Analysis·E Bossu'A Farina
Oct 3, 2002·Nature Reviews. Drug Discovery·Israel AgranatJohn Caldwell
Apr 15, 2004·Clinical Pharmacokinetics·Tommy Andersson
May 18, 2005·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Dion M A M LuykxPeter M J M Jongen
Mar 15, 2006·Analytical and Bioanalytical Chemistry·A GergelyG Veress
Mar 14, 2008·Journal of Chromatography. a·F G SánchezA B M de Vicente
Aug 29, 2017·Journal of Liquid Chromatography & Related Technologies·Douglas KirkpatrickMichael Trehy

❮ Previous
Next ❯

Citations

Jan 30, 2019·Pharmaceuticals·Marcin GóreckiGennaro Pescitelli
Mar 3, 2019·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Joana TeixeiraCarla Fernandes
Jan 18, 2020·Drug Development and Industrial Pharmacy·Priscila Debastiani BarrosÉlcio José Bunhak
Jan 23, 2021·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Yiwen YangQilong Ren

❮ 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.