Development of Validated and Stability-Indicating LC-DAD and LC-MS/MS Methods for Determination of Avanafil in Pharmaceutical Preparations and Identification of a Novel Degradation Product by LCMS-IT-TOF

Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry
Nafiz Oncu Can

Abstract

Avanafil (AVA), one of the most effective drugs prescribed for erectile dysfunction, is a pyrimidine-derivative PDE5 inhibitor. In the current work, new LC methods were developed and validated for quantitative determination of avanafil and qualitative determination of its degradation products. The quantitative determination of avanafil was carried out using liquid chromatography with photodiode array detection (LC-DAD) and liquid chromatography-tandem mass spectrometry LC-MS/MS methods, and fully validated according to the ICH Q2 (R1) guideline, while qualitative determination was performed using a liquid chromatography mass spectrometry-ion trap-time of flight (LCMS-IT-TOF) instrument. The separation of avanafil and its degradation products was carried out using the same reversed-phase chromatographic conditions, in which a second-generation C18-bonded monolithic silica column (Chromolith® High Resolution RP-18e, 100 × 4.6 mm, Merck KGaA) was used as stationary phase. Briefly, the methods enable quantitation of avanafil with high accuracy (recovery > 95%) and precision (RSD% < 2.0), within the ranges of 0.5⁻20 μg/mL for LC-DAD and 150⁻6000 ng/mL for LC-MS/MS. In the forced degradation studies, over and above currently existing...Continue Reading

References

Sep 19, 2002·Journal of Chromatography. a·Nobuo TanakTohru Ikegami
Oct 14, 2010·Expert Opinion on Investigational Drugs·Ma LiminWayne J G Hellstrom
Jun 7, 2011·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Flaubert MbeunkuiMary Ann Lila
Sep 14, 2012·Vascular Health and Risk Management·Ryan M Burke, Jeffery D Evans
Dec 25, 2012·Journal of Pharmaceutical and Biomedical Analysis·Daniel J MansConnie M Gryniewicz-Ruzicka
Feb 2, 2013·Therapeutic Advances in Urology·George T KediaKnut Albrecht
Mar 1, 2015·Journal of Chromatography. a·J RuščićM Krajačić
Nov 7, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Elnaz Tamizi, Abolghasem Jouyban
Jun 5, 2016·Journal of Pharmaceutical and Biomedical Analysis·Jialiang GuoZhengjin Jiang
Dec 13, 2016·International Journal of Pharmaceutics·Kareem AbuBakr SolimanMahmoud Mohammed Ghorab
Apr 11, 2018·International Journal of Pharmaceutics·Pinaki SenguptaRakesh Kumar Tekade

❮ Previous
Next ❯

Citations

Jul 15, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Michał StaniakWojciech Myśliński
Dec 22, 2021·Journal of Chromatographic Science·Gowri GolluSasikala Allam
Nov 13, 2020·Combinatorial Chemistry & High Throughput Screening·Serkan LeventNafiz Öncü Can

❮ Previous
Next ❯

Software Mentioned

LCMS
GraphPad Prism

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.