Utilization of Photochemically Induced Fluorescence Detection for HPLC Determination of Genotoxic Impurities in the Vortioxetine Manufacturing Process

Douša, Michal; Doubský, Jan; Srbek, Jan

doi:10.1093/chromsci/bmw116

Cited by 10 publications

(4 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…7). Therefore, aminosulfide and nitrosulfide impurities were confirmed as genotoxic, need to quantify by accurate, sensitive, and quantitative method such as RP-HPLC method in combination with PIF [25].…”

Section: Voriconazolementioning

confidence: 99%

Genotoxic Impurities: An Important Regulatory Aspect

Pounikar

Umekar

Gupta

2020

Asian J Pharm Clin Res

View full text Add to dashboard Cite

Genotoxins are agents/carriers such as chemical or radiation that can cause the damage to DNA or chromosomal structure, thereby causing mutations and the process are called as genotoxicity. Identification and understanding of genotoxins at a primary stage of drug development would enable us to prevent the potential damage that can be caused by these genotoxic agents. Various regulatory agencies such as International Council for Harmonization and EMEA, USFDA, European Pharmacopeia guidance, guidance for oncology products provide guidelines to limits the level of impurities in drug substances and drug products. Nowadays, conventional protocol of isolation, various spectral analysis high-performance liquid chromatography (LC), Fourier transform infrared to on-line analysis using modern, sophisticated hyphenated tools, like gas chromatography-mass spectroscopy, LC-MS so on, as well as modern software based in silico drug designs are extensively used by industry, research, and development areas and also there is tremendous increase in publications in the literature involving their use. Our review article focused on the various regulatory guidelines, application of hyphenated tools, and in silico techniques in genotoxic impurity and degradation product profiling of small molecules. A brief explanation is made on possible pitfalls in the experimentation and data interpretation. From this review, it concluded that there are various countries having their own regulatory agencies and regulatory guidelines for drug approvals, which may be followed by applying new chemical entities the new drug application title (NDA) in new drug application as well as there are various conventional to modern software based techniques to quantification of genotoxic impurities.

show abstract

Section: Voriconazolementioning

confidence: 99%

Genotoxic Impurities: An Important Regulatory Aspect

Pounikar

Umekar

Gupta

2020

Asian J Pharm Clin Res

View full text Add to dashboard Cite

show abstract

“…Soni and Sanjay developed an RP-HPLC method for the estimation of meloxicam and paracetamol with its GIs in bulk and combined dosage form using photodiode-array detection detector [15]. Dousa et al reported an RP-HPLC method for the analysis of GIs in the vortioxetine using a fluorescence detector [16].…”

Section: Hplcmentioning

confidence: 99%

A Review on Analytical Challenges in Monitoring and Controlling Genotoxic Impurities

Sutnga¹,

R²

2020

Asian J Pharm Clin Res

View full text Add to dashboard Cite

Genotoxic impurities (GIs) are chemical agents that have a DNA-interaction characteristic which can ultimately lead to cancer. Their presence in various drug substances had driven various regulatory authorities to guide monitor, control, and to limit their level in various drug products. The objective of this article is to review the analytical approaches and challenges faced while accessing, monitoring, and controlling GIs in pharmaceuticals and also a brief explanation such as low limits of GIs, matrix interference, non-volatility, and environmental conditions encountered during the analysis of GIs are also discussed in this paper. At present, several modern analytical techniques are being used for the analysis of GIs such as high-performance liquid chromatography, liquid chromatography-mass spectrometry, and gas chromatography-mass spectroscopy that have high selectivity and sensitivity, but at the same time, many researchers have reported several challenges while using these techniques. Impacts of GIs are very important and various international organizations such as the World Health Organization have set out rules for regulating these chemicals. Hence, we can conclude that analytical approaches and their challenges are essential to understand because they play a key role to develop robust analytical methods.

show abstract

“…These two last adsorbents can both be used in the pH range between 1 and 11. A wide number of published results in 24] and XSelect CSH C18 [25][26][27] can be found in literature. All three packings generally use alcohol:water or acetonitrile:water solvents, often with an acid or basic modifier (typically 0.1%).…”

Section: Introductionmentioning

confidence: 99%

Separation of nadolol racemates by high pH reversed-phase preparative chromatography

Arafah

Ribeiro

Rodrigues

et al. 2020

Separation and Purification Technology

View full text Add to dashboard Cite

The separation of nadolol racemates under high pH reversed-phase preparative chromatography is presented for the first time.Three Waters C18 adsorbents (XBridge, Shield and XSelect) are compared for the separation of nadolol racemates using ethanol:water:diethylamine solvent mixtures. Experimental and simulation results are presented to compare the separation performances at preparative scale using both the fixed-bed and the simulated moving bed operations.The Waters XBridge C18 adsorbent and an ethanol:water:diethylamine solvent mixture are selected as a good option for the separation of nadolol racemates. The validated methodology allows the separation of a multicomponent nadolol feed mixture composed by four stereoisomers into two pure racemates (two pairs of enantiomers). This work introduces the potential of using an initial achiral separation step in the global strategy for the complete multicomponent separation of the four nadolol stereoisomers.

show abstract

Utilization of Photochemically Induced Fluorescence Detection for HPLC Determination of Genotoxic Impurities in the Vortioxetine Manufacturing Process

Cited by 10 publications

References 27 publications

Genotoxic Impurities: An Important Regulatory Aspect

Genotoxic Impurities: An Important Regulatory Aspect

A Review on Analytical Challenges in Monitoring and Controlling Genotoxic Impurities

Separation of nadolol racemates by high pH reversed-phase preparative chromatography

Contact Info

Product

Resources

About